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510(k) K830365

KINETI COUNT 48 IMMUNOASSAY SYSTEM by Medical & Scientific Designs, Inc. — Product Code JJJ

K830365 is an FDA 510(k) premarket notification submitted by Medical & Scientific Designs, Inc. for the device "KINETI COUNT 48 IMMUNOASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 10, 1983. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Medical & Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1983
Date Received
February 4, 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 Medical & Scientific Designs, Inc.

  • K862960 — PHASE II FERRITIN RADIOIMMUNOASSAY KIT (August 27, 1986)
  • K853224 — PHASE II B-12/FOLATE KIT (October 3, 1985)
  • K840901 — PHASE II FREE T4 KIT (April 25, 1984)
  • K840328 — PHASE II HCG KIT (April 19, 1984)
  • K834219 — PHASE II CORTISOL KIT (February 4, 1984)
  • K833789 — PHASE II THEOPHYLLINE RADIOIMMUNOASSAY (January 24, 1984)
  • K832499 — PHASE II TSH KIT (September 12, 1983)
  • K832210 — GAMMA PHOTON GAMMA COUNTER (August 24, 1983)
  • K832209 — KINETI COUNT 24 GAMMA COUNTER (August 24, 1983)
  • K831064 — PHASE II T3 RADIOIMMUNOASSAY KIT (May 9, 1983)

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