Product code JJI
- Device name
- Analyzer, Enzyme, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2500
- Review panel
- CH
- 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 |
|---|---|---|---|
| K972024 | CODA AUTOMATED EIA ANALYZER | Bio-Rad | 1997-07-30 |
| K944731 | ABBOTT IMX 2 ANALYZER | Abbott Laboratories | 1994-12-19 |
| K931970 | ABBOTT IMX2 ANALYER | Abbott Laboratories | 1993-06-16 |
| K930898 | RADIAS AUTOMATED IMMUNOASSAY SYSTEM | Bio-Rad | 1993-04-21 |
| K790073 | ANALYZER, IMPACT 100 | Gilford Instrument Laboratories, Inc. | 1979-02-22 |
| K780972 | QUICKRATE REACTION RATE ANALYZER | Olympus Corp. | 1978-08-14 |
| K771591 | MINISTAT-S CHEMISTRY ANALYZER | Biokinetix Corp. | 1977-09-20 |
| K770401 | LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05700699457110 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457264 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457257 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457240 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457226 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457219 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457202 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457196 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457189 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457172 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457165 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457158 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457141 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457134 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457127 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700693938417 | ABL80 FLEX CO-OX Analyzer | Radiometer Medical ApS | 2016-09-01 |
| 05700699457103 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457097 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457080 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457073 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457066 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457059 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457042 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457035 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457028 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457011 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699457004 | ABL80 SC80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699443410 | ABL80 FLEX SP80 | Radiometer Medical ApS | 2016-09-01 |
| 05700699442529 | ABL80 FLEX SP80 CO-OX | Radiometer Medical ApS | 2016-09-01 |
| 05700699060259 | ABL80 CO-OX Capillary adapter | Radiometer Medical ApS | 2016-09-01 |