Home / 510(k) Clearances / K832002

510(k) K832002

NML-5010/5020 MULTI-DETECTOR SYSTEM by Nuclear Medical Laboratories, Inc. — Product Code JJJ

K832002 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "NML-5010/5020 MULTI-DETECTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on August 8, 1983. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Nuclear Medical Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1983
Date Received
June 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter (Beta, Gamma) For Clinical Use
Device Class
Class I
Regulation Number
862.2320
Review Panel
CH
Submission Type

Other clearances by Nuclear Medical Laboratories, Inc.

  • K852438 — NML TSH IRMA (July 12, 1985)
  • K844583 — TSH-STAT (March 5, 1985)
  • K840466 — NML CORTISOL RIA (March 30, 1984)
  • K840589 — TRI-TUBE RIA (March 9, 1984)
  • K832892 — MODIFIED CHORIO-SHURE (October 28, 1983)
  • K823679 — NML 6000 CT (January 7, 1983)
  • K823053 — NML-TETRA-TUBE RIA (November 10, 1982)
  • K822298 — DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI (September 2, 1982)
  • K820523 — CHORIO-QUANT (March 15, 1982)
  • K812759 — NML CK-MB RIA (October 19, 1981)

Other clearances for product code JJJ

  • K962762 — SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (August 16, 1996)
  • K946387 — CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER (March 30, 1995)
  • K920559 — ABBOTT VERTEX ANALYZER (March 19, 1992)
  • K900087 — GENESYS 6000 GAMMA COUNTER (July 19, 1990)
  • K896202 — MATRIX(TM)-96 (January 2, 1990)
  • K894902 — SOURCERER (October 17, 1989)
  • K884091 — SOURCERER (February 2, 1989)
  • K884269 — SAMPLE IDENTIFICATION STATION MODEL 38010 (January 9, 1989)
  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 1987)
  • K872430 — ISO-DATA 500 SERIES GAMMA COUNTER (August 21, 1987)

FDA data resources