Clinical Controls, Inc. FDA Record
- No warning letters matched by name
Clinical Controls, Inc. has 0 FDA recalls, 0 inspections, 18 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Clinical Controls, Inc." is on file.
- Latest 510(k)
- Sep 28, 2001
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 18 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K012907 | LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL | Sep 28, 2001 |
| K964278 | WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND… | Nov 22, 1996 |
| K962432 | LIQUISPEX URINE (MICRO)ALBUMIN CONTROL | Jul 5, 1996 |
| K955690 | AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 | Apr 24, 1996 |
| K955691 | SERUM VOLATILES CONTROL LEVEL 1 & 2 | Apr 24, 1996 |
| K946265 | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 | Aug 24, 1995 |
| K935598 | PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 | May 2, 1995 |
| K946049 | LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 | Feb 10, 1995 |
| K946266 | FERRITIN CONTROL - LEVEL 1, 2, 3 | Feb 10, 1995 |
| K946048 | LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 | Feb 10, 1995 |
| K946050 | LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 | Feb 10, 1995 |
| K946144 | LIQUISPEX(TM) URINE ETHANOL CONTROL | Feb 8, 1995 |
| K946143 | CHEMSPEX(TM) AMMONIA CONTROL | Feb 3, 1995 |
| K946146 | CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION | Jan 24, 1995 |
| K946145 | CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL | Jan 24, 1995 |
| K944923 | CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, | Nov 4, 1994 |
| K935599 | HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 | Oct 31, 1994 |
| K934741 | LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 | Sep 8, 1994 |
Clinical Controls, Inc. and the FDA: common questions
Has Clinical Controls, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Clinical Controls, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Clinical Controls, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Clinical Controls, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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