GMP — Antisera, Control For Nontreponemal Tests Class II
FDA Device Classification
Classification Details
- Product Code
- GMP
- Device Class
- Class II
- Regulation Number
- 866.3820
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K980638 | ampcor diagnostics | ADI SYPHILIS RPR LIQUID CONTROLS | July 6, 1998 |
| K961998 | consolidated technologies | QUALITROL SYPHSERO CONTROL SET | August 8, 1996 |
| K955143 | remel, l.p | RPR LIQUID CONTROLS | July 30, 1996 |
| K885298 | allelix diagnostics | VISUWELL REAGIN TEST 960 TEST KIT | March 15, 1989 |
| K875180 | texas immunology | V-TREND RPRL CARD TEST | February 4, 1988 |
| K851504 | ncs diagnostics | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 | August 19, 1985 |
| K843741 | biokit usa | RPR TEST REDITEST | October 25, 1984 |
| K812425 | beckman instruments | BECKMAN R.PR CONTROL SERUM SET | September 23, 1981 |
| K810119 | hillside acres | CONTROL SERUMS FOR NONTREPONEMAL TEST | February 9, 1981 |