Product code GMP— Microbiology
ADI SYPHILIS RPR LIQUID CONTROLS
- Classification name
- Antisera, Control For Nontreponemal Tests
- Device class
- Class 2
- Regulation
- 21 CFR 866.3820
- Advisory panel
- Microbiology
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code GMP
FDA has cleared devices under product code GMP between 1981 and 1998, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1998
- 1996
- 1989
- 1988
- 1985
- 1984
- 1981
Top applicants under product code GMP
Recent clearances under product code GMP
- K980638 — ADI SYPHILIS RPR LIQUID CONTROLS
- K961998 — QUALITROL SYPHSERO CONTROL SET
- K955143 — RPR LIQUID CONTROLS
- K885298 — VISUWELL REAGIN TEST 960 TEST KIT
- K875180 — V-TREND RPRL CARD TEST
- K851504 — VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
- K843741 — RPR TEST REDITEST
- K812425 — BECKMAN R.PR CONTROL SERUM SET
- K810119 — CONTROL SERUMS FOR NONTREPONEMAL TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.