Neogenex FDA Record
Neogenex has 0 FDA recalls, 0 inspections, 20 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Neogenex" is on file.
- Latest 510(k)
- Feb 4, 1997
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 20 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 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 |
|---|---|---|
| K965047 | MINK LUNG CELL CULTURE | Feb 4, 1997 |
| K960909 | H292 CELL CULTURE | May 30, 1996 |
| K943885 | PRIMARY RABBIT KIDNEY CELL CULTURE | Nov 28, 1994 |
| K943888 | MDCK CELL CULTURE | Nov 28, 1994 |
| K943889 | VERO CELL CULTURE | Nov 28, 1994 |
| K943887 | HUMAN NEWBORN FORESKIN CELL CULTURE | Nov 28, 1994 |
| K943890 | WI38 CELL CULTURE | Nov 28, 1994 |
| K943891 | RD CULTURE CELL | Nov 28, 1994 |
| K943884 | PRIMARY MONKEY KIDNEY CELL CULTURE | Nov 28, 1994 |
| K943886 | BGM CELL CULTURE | Nov 28, 1994 |
| K941714 | CHLAMYDIA TRACHOMATIS ANTIGEN TEST | Jul 18, 1994 |
| K942172 | INFLUENZA A ANTIGEN TEST | Jul 6, 1994 |
| K942174 | INFLUENZA B ANITGEN TEST | Jun 30, 1994 |
| K942171 | CMV EARLY ANTIGEN TEST | Jun 30, 1994 |
| K942173 | RSV ANTIGEN TEST | Jun 30, 1994 |
| K933927 | HEP-2 CULTURE CELL | Mar 31, 1994 |
| K933924 | MCCOY CULTURE CELL | Mar 29, 1994 |
| K933923 | A549 CULTURE CELL | Mar 29, 1994 |
| K933925 | MRC-5 CULTURE CELL | Mar 29, 1994 |
| K933926 | LLCMK2 CULTURE CELLS | Mar 29, 1994 |
Neogenex and the FDA: common questions
Has Neogenex received an FDA warning letter?
No FDA warning letter addressed to the name "Neogenex" 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 Neogenex received an FDA Form 483?
FDA has not published a Form 483 for "Neogenex" in its reading room. FDA publishes some Form 483s, not all of them.
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