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510(k) K780790

IDI 200 GAMMA COUNTER by Iso-Data, Inc. — Product Code JJJ

K780790 is an FDA 510(k) premarket notification submitted by Iso-Data, Inc. for the device "IDI 200 GAMMA COUNTER". The FDA issued a decision of Substantially Equivalent on June 22, 1978. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Iso-Data, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1978
Date Received
May 15, 1978
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 Iso-Data, Inc.

  • K872430 — ISO-DATA 500 SERIES GAMMA COUNTER (August 21, 1987)
  • K872429 — ISO-DATA 100 SERIES GAMMA COUNTER (August 21, 1987)
  • K843434 — ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. (October 5, 1984)
  • K843365 — ISO-DATA IMMUNOASSAY NETWORK SYSTEM (September 27, 1984)
  • K810631 — DPM CALCULATOR (March 27, 1981)
  • K780813 — IDI GDR DATA REDUCTION SYSTEM (June 28, 1978)

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