JSK — Supplement, Culture Media Class I
FDA product code JSK covers "Supplement, Culture Media", a Class I medical device regulated under 21 CFR 866.2450. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JSK
- Device Class
- Class I
- Regulation Number
- 866.2450
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K881949 | alpha-tec systems | ATS NAC-PAC SET | May 25, 1988 |
| K881879 | alpha-tec systems | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 | May 13, 1988 |
| K881566 | acumedia manufacturers | HEMOGLOBIN POWDER | April 18, 1988 |
| K861997 | hazleton research products | PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE | June 10, 1986 |
| K861823 | flow laboratories | GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) | May 20, 1986 |
| K861791 | flow laboratories | PENICILLIN-STREPTOMYCIN-FUNGIZONE | May 20, 1986 |
| K861824 | flow laboratories | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | May 20, 1986 |
| K855172 | micro-bio-logics | KWI (TM) G-CO/TWO | February 20, 1986 |
| K853546 | abbott laboratories | ABBOTT CATION SUPPLEMENT SOLUTION | September 6, 1985 |
| K850302 | pro-lab | SUPLEX & SUPLEX DILUENT | March 22, 1985 |
| K850738 | roseville medical laboratoriesu | SUPPLEMENT FOR CULTURE MEDIUM | March 20, 1985 |
| K850301 | pro-lab | YEAST DIALYSATE | March 20, 1985 |
| K850300 | pro-lab | MUCOLYSE | March 20, 1985 |
| K850307 | pro-lab | CAMPYLOBACTER SUPPLEMENT-BLASER/WANG | March 20, 1985 |
| K850308 | pro-lab | C.L.A.T. | March 20, 1985 |
| K850299 | pro-lab | C.N.V.T. | March 20, 1985 |
| K850306 | pro-lab | CAMPYLOBACTER SUPPLEMENT -SKIRROW | March 20, 1985 |
| K840333 | oxoid u.s.a | LEGIONELLA BMPA SELECTIVE SUPPLE | May 11, 1984 |
| K840331 | oxoid u.s.a | LEGIONELLA MWY SELECTIVE SUPPLEMENT | May 11, 1984 |
| K840330 | oxoid u.s.a | PRESTON CAMPYLOBACTER SELECTIVE SUPP | May 11, 1984 |