Johnson & Johnson Clinical Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 33
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K980283 | VITROS CHEMISTRY PRODUCTS CRBM SLIDES | February 25, 1998 |
| K974644 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | January 13, 1998 |
| K973517 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | September 25, 1997 |
| K973030 | VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) | September 4, 1997 |
| K972133 | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GE | June 24, 1997 |
| K970894 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM. | April 14, 1997 |
| K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) | March 18, 1997 |
| K965142 | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) | March 18, 1997 |
| K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS | February 25, 1997 |
| K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) | February 20, 1997 |
| K964960 | VITROS CHEMISTRY PRODUCTS UPRO SLIDES | February 18, 1997 |
| K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) | February 4, 1997 |
| K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) | January 30, 1997 |
| K965048 | VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) | January 27, 1997 |
| K964721 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) | December 18, 1996 |
| K964558 | VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) | December 16, 1996 |
| K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010 | November 27, 1996 |
| K964308 | VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C | November 27, 1996 |
| K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM | October 18, 1996 |
| K962235 | VITROS SPECIALTY DILUENT | June 26, 1996 |