FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
FDA premarket approval P770001 · decided 1979-07-18
Approval details
- PMA number
- P770001
- Trade name
- FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
- Generic name
- GONOCOCCAL ANTIBODY TESTS
- Applicant
- Fisher Scientific Co., LLC
- Date received
- 1977-05-20
- Decision date
- 1979-07-18
- Days to decision
- 789 days
- Decision code
- APPR
- Product code
- LGB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Orangeburg, NY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MICROHEMATOCRIT ROTOR (K930415) | Fisher Scientific Co., LLC | 1993-03-23 |
| MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (K915825) | Fisher Scientific Co., LLC | 1992-03-11 |
| MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (K915441) | Fisher Scientific Co., LLC | 1992-01-08 |
| MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 (K890534) | Fisher Scientific Co., LLC | 1989-03-08 |
| URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II (K881275) | Fisher Scientific Co., LLC | 1988-05-16 |
| FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (K874054) | Fisher Scientific Co., LLC | 1987-10-20 |
| HISTOMATIC SLIDE STAINER, CODE-ON VERSION (K872916) | Fisher Scientific Co., LLC | 1987-09-14 |
| SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) (K871058) | Fisher Scientific Co., LLC | 1987-04-06 |