Panels › Microbiology › Product code GTJ · Class 2
Antisera, All Groups, N. Meningitidis
Regulation 866.3390
0510(k)s in 12 months (16 all time)
1recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in GTJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Wellcome Diagnostics | 5 | 0 |
| BD Diagnostic Systems / Lee Laboratories | 0 | 4 |
| Armkel, LLC | 3 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 0 |
| Pharmacia, Inc. | 2 | 0 |
| Burroughs Wellcome Co. | 1 | 0 |
| Microscan Div. Baxter Healthcare Corp. | 1 | 0 |
| Remel Europe Ltd. | 0 | 1 |
| Vitek Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 30, 1996 | K952791 | DIRECTIGEN MENINGITIS COMBO TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | GTJ |
| Mar 23, 1992 | K915330 | DIRECTIGEN MENINGITIS COMBO TEST KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | GTJ |
| Aug 12, 1991 | K910210 | SLIDEX MENINGITE-KIT 5 Vitek Systems, Inc. | GTJ |
| Feb 7, 1989 | K885004 | BACTIGEN(R) N. MENINGITIDIS Armkel, LLC | GTJ |
| Mar 17, 1987 | K870089 | IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT Microscan Div. Baxter Healthcare Corp. | GTJ |
| Feb 4, 1986 | K854852 | WELLCOGEN BACTERIAL ANTIGEN KIT Wellcome Diagnostics | GTJ |
| Feb 4, 1986 | K854851 | WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 Wellcome Diagnostics | GTJ |
| Oct 17, 1985 | K844999 | PHADEBACT CSF TEST Pharmacia, Inc. | GTJ |
| Jun 10, 1985 | K851691 | WILLCOGEN MENINGITIDIS KIT ZL25 Wellcome Diagnostics | GTJ |
| Jun 4, 1985 | K844762 | MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 Wellcome Diagnostics | GTJ |
| Jan 25, 1985 | K844407 | DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | GTJ |
| Jul 6, 1984 | K841907 | BACTIGEN - N.MENNINIGITIDIS TEST Armkel, LLC | GTJ |
| Jan 10, 1984 | K833063 | WELLCOGEN N. MENINGITIDIS A,C,Y W135 Wellcome Diagnostics | GTJ |
| Mar 9, 1983 | K823880 | BACTIGEN-N. MENINGITIDIS Armkel, LLC | GTJ |
| Dec 30, 1982 | K822810 | PHADEBACT CSF TEST 20 Pharmacia, Inc. | GTJ |
| Aug 25, 1977 | K771562 | AGGLUTINATING SERUM W135 Burroughs Wellcome Co. | GTJ |
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