Panels › Microbiology › Product code GMP · Class 2
Antisera, Control For Nontreponemal Tests
Regulation 866.3820
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GMP
| Company | 510(k)s | Recalls |
|---|---|---|
| Allelix Diagnostics, Inc. | 1 | 0 |
| Ampcor Diagnostics, Inc. | 1 | 0 |
| Beckman Instruments, Inc. | 1 | 0 |
| Biokit USA, Inc. | 1 | 0 |
| Consolidated Technologies, Inc. | 1 | 0 |
| Hillside Acres, Inc. | 1 | 0 |
| Ncs Diagnostics, Inc. | 1 | 0 |
| Remel, L.P. | 1 | 0 |
| Texas Immunology, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 1998 | K980638 | ADI SYPHILIS RPR LIQUID CONTROLS Ampcor Diagnostics, Inc. | GMP |
| Aug 8, 1996 | K961998 | QUALITROL SYPHSERO CONTROL SET Consolidated Technologies, Inc. | GMP |
| Jul 30, 1996 | K955143 | RPR LIQUID CONTROLS Remel, L.P. | GMP |
| Mar 15, 1989 | K885298 | VISUWELL REAGIN TEST 960 TEST KIT Allelix Diagnostics, Inc., CA | GMP |
| Feb 4, 1988 | K875180 | V-TREND RPRL CARD TEST Texas Immunology, Inc. | GMP |
| Aug 19, 1985 | K851504 | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 Ncs Diagnostics, Inc., CA | GMP |
| Oct 25, 1984 | K843741 | RPR TEST REDITEST Biokit USA, Inc. | GMP |
| Sep 23, 1981 | K812425 | BECKMAN R.PR CONTROL SERUM SET Beckman Instruments, Inc. | GMP |
| Feb 9, 1981 | K810119 | CONTROL SERUMS FOR NONTREPONEMAL TEST Hillside Acres, Inc. | GMP |
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