JJJ · Counter (Beta, Gamma) For Clinical Use
Clinical Chemistry · 21 CFR 862.2320 · Class 1
Overview
| Product Code | JJJ |
|---|---|
| Device Name | Counter (Beta, Gamma) For Clinical Use |
| Regulation | 21 CFR 862.2320 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 63)
Showing 20 most recent of 63 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962762 | SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR | Biotraces, Inc. | Aug 16, 1996 | SESE |
| K946387 | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER | Capintec, Inc. | Mar 30, 1995 | SESE |
| K920559 | ABBOTT VERTEX ANALYZER | Abbott Laboratories | Mar 19, 1992 | SESE |
| K900087 | GENESYS 6000 GAMMA COUNTER | Laboratory Technologies, Inc. | Jul 19, 1990 | SESE |
| K896202 | MATRIX(TM)-96 | Canberra Industries, Inc. | Jan 2, 1990 | SESE |
| K894902 | SOURCERER | Oakfield Instruments, Ltd. | Oct 17, 1989 | SESE |
| K884091 | SOURCERER | John Caunt Scientific , Ltd. | Feb 2, 1989 | SESE |
| K884269 | SAMPLE IDENTIFICATION STATION MODEL 38010 | Icn Micromedic Systems | Jan 9, 1989 | SESE |
| K874094 | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | Lkb Instruments, Inc. | Nov 4, 1987 | SESE |
| K872430 | ISO-DATA 500 SERIES GAMMA COUNTER | Iso-Data, Inc. | Aug 21, 1987 | SESE |
| K872429 | ISO-DATA 100 SERIES GAMMA COUNTER | Iso-Data, Inc. | Aug 21, 1987 | SESE |
| K870115 | BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS | Berthold Analytical Instruments, Inc. | Mar 31, 1987 | SESE |
| K862206 | TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER | Micromedic Systems | Aug 4, 1986 | SESE |
| K851164 | DENTOCULT CULTURE-PADDLE | Orion Corp. | Oct 29, 1985 | SESE |
| K851689 | GENESYS GAMMA COUNTER | Laboratory Technologies, Inc. | Aug 7, 1985 | SESE |
| K852434 | 1208 BETACORD AND 1208 BETCORD M | Lkb Instruments, Inc. | Aug 2, 1985 | SESE |
| K842902 | MICROSTAT GAMMA COUNTER | Micromedic Systems | Aug 9, 1984 | SESE |
| K841352 | ND1200 RIA COUNTER | Nuclear Data, Inc. | May 2, 1984 | SESE |
| K834508 | CORNING 4000 MULTI-WELL GAMMA COUNTER | Corning Medical & Scientific | Mar 16, 1984 | SESE |
| K832734 | KEMTEK 400 RIA GAMMA COUNTER | Kemble Instruments, Inc. | Oct 14, 1983 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 7 clearances
- Kemble Instruments, Inc. — 6 clearances
- Lkb Instruments, Inc. — 5 clearances
- Abbott Laboratories — 4 clearances
- Micromedic Systems — 4 clearances
