510(k) K900087
- Device
- GENESYS 6000 GAMMA COUNTER
- Applicant
- LABORATORY TECHNOLOGIES, INC.
- 510(k) number
- K900087
- Product code
- JJJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-19
- Date received
- 1990-01-05
- Regulation
- 862.2320
- Classification name
- Counter (beta, Gamma) For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- J SCHMIDT
- Address
- 1517 S. Wright Schaumburg IL US 60193 60193
FDA Registration Numbers#
- 3004049804
- 3003529145
- 1219913
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JJJ #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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