JJJ — Counter (Beta, Gamma) For Clinical Use Class I
FDA Device Classification
Classification Details
- Product Code
- JJJ
- Device Class
- Class I
- Regulation Number
- 862.2320
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K962762 | biotraces | SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR | August 16, 1996 |
| K946387 | capintec | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER | March 30, 1995 |
| K920559 | abbott laboratories | ABBOTT VERTEX ANALYZER | March 19, 1992 |
| K900087 | laboratory technologies | GENESYS 6000 GAMMA COUNTER | July 19, 1990 |
| K896202 | canberra industries | MATRIX(TM)-96 | January 2, 1990 |
| K894902 | oakfield instruments | SOURCERER | October 17, 1989 |
| K884091 | john caunt scientific | SOURCERER | February 2, 1989 |
| K884269 | icn micromedic systems | SAMPLE IDENTIFICATION STATION MODEL 38010 | January 9, 1989 |
| K874094 | lkb instruments | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | November 4, 1987 |
| K872429 | iso-data | ISO-DATA 100 SERIES GAMMA COUNTER | August 21, 1987 |
| K872430 | iso-data | ISO-DATA 500 SERIES GAMMA COUNTER | August 21, 1987 |
| K870115 | berthold analytical instruments | BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS | March 31, 1987 |
| K862206 | micromedic systems | TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER | August 4, 1986 |
| K851164 | orion | DENTOCULT CULTURE-PADDLE | October 29, 1985 |
| K851689 | laboratory technologies | GENESYS GAMMA COUNTER | August 7, 1985 |
| K852434 | lkb instruments | 1208 BETACORD AND 1208 BETCORD M | August 2, 1985 |
| K842902 | micromedic systems | MICROSTAT GAMMA COUNTER | August 9, 1984 |
| K841352 | nuclear data | ND1200 RIA COUNTER | May 2, 1984 |
| K834508 | corning medical and scientific | CORNING 4000 MULTI-WELL GAMMA COUNTER | March 16, 1984 |
| K832734 | kemble instruments | KEMTEK 400 RIA GAMMA COUNTER | October 14, 1983 |