GMP
9 FDA 510(k) clearances · Product code
78 daysmedian time to decision
260 days90th percentile
9clearances measured
FDA profile
- Official device name
- Antisera, Control For Nontreponemal Tests
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3820
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ADI SYPHILIS RPR LIQUID CONTROLS (K980638) | Ampcor Diagnostics, Inc. | 1998-07-06 |
| QUALITROL SYPHSERO CONTROL SET (K961998) | Consolidated Technologies, Inc. | 1996-08-08 |
| RPR LIQUID CONTROLS (K955143) | Remel, L.P. | 1996-07-30 |
| VISUWELL REAGIN TEST 960 TEST KIT (K885298) | Allelix Diagnostics, Inc. | 1989-03-15 |
| V-TREND RPRL CARD TEST (K875180) | Texas Immunology, Inc. | 1988-02-04 |
| VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 (K851504) | Ncs Diagnostics, Inc. | 1985-08-19 |
| RPR TEST REDITEST (K843741) | Biokit USA, Inc. | 1984-10-25 |
| BECKMAN R.PR CONTROL SERUM SET (K812425) | Beckman Instruments, Inc. | 1981-09-23 |
| CONTROL SERUMS FOR NONTREPONEMAL TEST (K810119) | Hillside Acres, Inc. | 1981-02-09 |
Track GMP automatically
Every clearance here is in the API, with alerts when new ones post.