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510(k) K821494

RIA STAT 16 by E. R. Squibb & Sons, Inc. — Product Code JJJ

K821494 is an FDA 510(k) premarket notification submitted by E. R. Squibb & Sons, Inc. for the device "RIA STAT 16". The FDA issued a decision of Substantially Equivalent on June 3, 1982. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. E. R. Squibb & Sons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1982
Date Received
May 18, 1982
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 E. R. Squibb & Sons, Inc.

  • K820616 — ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY (March 26, 1982)
  • K820340 — T3 UPTAKE-SQUIBB DIAGNOSTIC KIT (March 4, 1982)
  • K820341 — CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT (March 4, 1982)
  • K811240 — SUR-FIT LOOP OSTOMY O.R. SET (June 16, 1981)
  • K811239 — SUR-FIT DISPOSABLE CONVEX INSERT (June 9, 1981)
  • K811160 — SUR-FIT IRRIGATION SLEEVE (June 2, 1981)
  • K811163 — SUR-FIT DISPOSABLE FANGE CAP (May 21, 1981)
  • K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (April 21, 1981)
  • K810211 — T3 RIA KIT (February 10, 1981)
  • K803100 — STOMAHESIVE PASTE PROTECTIVE SKIN BARR (January 8, 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