Product code JSP
- Device name
- Kit, Anaerobic Identification
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945489 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 |
| K945488 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 |
| K945487 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 |
| K944528 | BBLCRYSTAL ANAEROBE ID SYSTEM | Becton Dickinson Microbiology Systems | 1995-03-07 |
| K910666 | VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION | Vitek Systems, Inc. | 1991-04-03 |
| K900996 | VITEK ANAEROBE IDENTIFICATION CARD | Vitek Systems, Inc. | 1990-05-11 |
| K881380 | B. FRAGTEX | American Biomedical Products, Inc. | 1988-10-06 |
| K882960 | IDS RAPID ANA SYSTEM | Innovative Diagnostic Systems, Inc. | 1988-08-12 |
| K855235 | DIAGNOSTIC REAGENT PET-RPLA | Oxoid U.S.A., Inc. | 1986-11-04 |
| K862332 | ANAEROBE RAPID CHROMOGENIC ID PANEL | American Micro Scan | 1986-08-27 |
| K850052 | ANAEROBE KIT | Austin Biological Laboratories | 1985-03-05 |
| K843686 | AMS ANA CARD | Vitek Systems, Inc. | 1984-12-12 |
| K831032 | API ANAIDENT | Analytical Products, Inc. | 1983-05-05 |
| K830964 | ANAEROBE MIC/ID TEMPLATE, & TAXONOMY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-05-04 |
| K820483 | IDA RAPID O2A SYSTEM | Innovative Diagnostic Systems, Inc. | 1982-03-15 |
| K802626 | ANAIROBE-TEK | Flow Laboratories, Inc. | 1980-11-12 |
| K801547 | TEST PANEL FOR PRESUMP. ID/BACT. ORG | Micro-Media Systems, Inc. | 1980-09-09 |
| K771616 | API 20A | Analytical Products, Inc. | 1977-09-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590657352 | MicroScan | Beckman Coulter, Inc. | 2022-12-05 |
| 05032384028528 | PET RPLA KIT | OXOID LIMITED | 2022-12-04 |
| 15099590655907 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590655983 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 00848838058035 | Remel | REMEL, INC. | 2021-11-12 |
| 30848838058036 | Remel | REMEL, INC. | 2021-11-12 |
| 03848838058032 | Remel | REMEL, INC. | 2021-11-12 |
| 03573026529727 | VITEK® 2 ANC | BIOMERIEUX , INC. | 2020-06-02 |
| 03573026144364 | VITEK® 2 ANC | BIOMERIEUX , INC. | 2020-06-02 |
| 03573026588564 | RAPID ID 32 A | BIOMERIEUX SA | 2020-04-10 |
| 03573026048150 | API® 20 A | BIOMERIEUX SA | 2020-04-10 |
| 03573026066420 | rapid ID 32 A | BIOMERIEUX SA | 2020-04-10 |
| 30382902450109 | BD BBL™ Crystal™ ANR | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902450383 | BD BBL™ Crystal™ ANR, GP, RGP, N/H ID Inoculum Fluid | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382902450115 | BD BBL™ Crystal™ ID Systems Anaerobe Manual Codebook | BECTON, DICKINSON AND COMPANY | 2018-05-25 |