Product code JJJ
- Device name
- Counter (Beta, Gamma) For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2320
- 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 |
|---|---|---|---|
| K962762 | SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR | Biotraces, Inc. | 1996-08-16 |
| K946387 | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER | Capintec, Inc. | 1995-03-30 |
| K920559 | ABBOTT VERTEX ANALYZER | Abbott Laboratories | 1992-03-19 |
| K900087 | GENESYS 6000 GAMMA COUNTER | Laboratory Technologies, Inc. | 1990-07-19 |
| K896202 | MATRIX(TM)-96 | Canberra Industries, Inc. | 1990-01-02 |
| K894902 | SOURCERER | Oakfield Instruments, Ltd. | 1989-10-17 |
| K884091 | SOURCERER | John Caunt Scientific , Ltd. | 1989-02-02 |
| K884269 | SAMPLE IDENTIFICATION STATION MODEL 38010 | Icn Micromedic Systems | 1989-01-09 |
| K874094 | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | Lkb Instruments, Inc. | 1987-11-04 |
| K872430 | ISO-DATA 500 SERIES GAMMA COUNTER | Iso-Data, Inc. | 1987-08-21 |
| K872429 | ISO-DATA 100 SERIES GAMMA COUNTER | Iso-Data, Inc. | 1987-08-21 |
| K870115 | BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS | Berthold Analytical Instruments, Inc. | 1987-03-31 |
| K862206 | TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER | Micromedic Systems | 1986-08-04 |
| K851164 | DENTOCULT CULTURE-PADDLE | Orion Corp. | 1985-10-29 |
| K851689 | GENESYS GAMMA COUNTER | Laboratory Technologies, Inc. | 1985-08-07 |
| K852434 | 1208 BETACORD AND 1208 BETCORD M | Lkb Instruments, Inc. | 1985-08-02 |
| K842902 | MICROSTAT GAMMA COUNTER | Micromedic Systems | 1984-08-09 |
| K841352 | ND1200 RIA COUNTER | Nuclear Data, Inc. | 1984-05-02 |
| K834508 | CORNING 4000 MULTI-WELL GAMMA COUNTER | Corning Medical & Scientific | 1984-03-16 |
| K832734 | KEMTEK 400 RIA GAMMA COUNTER | Kemble Instruments, Inc. | 1983-10-14 |
| K832736 | KEMTEK 104 RIA GAMMA COUNTER | Kemble Instruments, Inc. | 1983-09-29 |
| K832735 | KEMTEK 103 RIA GAMMA COUNTER | Kemble Instruments, Inc. | 1983-09-29 |
| K832210 | GAMMA PHOTON GAMMA COUNTER | Medical & Scientific Designs, Inc. | 1983-08-24 |
| K832209 | KINETI COUNT 24 GAMMA COUNTER | Medical & Scientific Designs, Inc. | 1983-08-24 |
| K832002 | NML-5010/5020 MULTI-DETECTOR SYSTEM | Nuclear Medical Laboratories, Inc. | 1983-08-08 |
| K830751 | KEMTEK 102 | Kemble Instruments, Inc. | 1983-04-06 |
| K830365 | KINETI COUNT 48 IMMUNOASSAY SYSTEM | Medical & Scientific Designs, Inc. | 1983-03-10 |
| K823240 | CAP-RIA 16 | Capintec, Inc. | 1982-12-03 |
| K822293 | IMMU-COUNT 404 | Kemble Instruments, Inc. | 1982-08-24 |
| K821892 | PHILLIPS RADIATION MEASURING INSTRUMENT | Long Island Scientific | 1982-07-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812589020429 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |
| 00812589020436 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |
| 00812589020443 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |
| 00812589020450 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |
| 00812589020467 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |
| 00812589020474 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |
| 00812589020481 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |
| 00812589020498 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |
| 00812589020504 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |
| 00812589020528 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |
| 00812589020535 | WIZARD² Gamma Counter | REVVITY SINGAPORE PTE. LTD. | 2020-05-14 |