GNA — Antisera, All Types, Escherichia Coli Class I
FDA product code GNA covers "Antisera, All Types, Escherichia Coli", a Class I medical device regulated under 21 CFR 866.3255. Submissions are reviewed by the Microbiology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GNA
- Device Class
- Class I
- Regulation Number
- 866.3255
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K071799 | iverness medical professional diagnostics | MODIFICATION TO BIOSTAR OIA SHIGATOX | October 2, 2007 |
| K031367 | emd chemicals | DUOPATH VEROTOXINS GLISA TEST | January 23, 2004 |
| K993401 | oxoid | DRYSPOT E.COLI 0157 KIT | February 28, 2000 |
| K981734 | denka seiken | VTEC-RPLA SEIKEN | September 22, 1998 |
| K962028 | murex diagnostics | WELLCOLEX E-COLI OI57 ZC60 | November 1, 1996 |
| K953362 | meridian diagnostics | PREMIER EHEC | November 14, 1995 |
| K950167 | meridian diagnostics | PREMIER EHEC | April 14, 1995 |
| K933457 | remel | RIM E.COLI 0157:H7 LATEX TEST | April 20, 1994 |
| K903714 | pro-lab | E. COLI 0157 LATEX TEST | January 24, 1991 |
| K884026 | oxoid u.s.a | ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT | February 3, 1989 |
| K874288 | pharmacia | PHADEBACT ETEC-LT TEST | September 2, 1988 |
| K855234 | oxoid u.s.a | DIAGNOSTIC REAGENT VET-RPLA | November 4, 1986 |