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510(k) K770726

RIA KIT, T4 CLASP by Squibb & Sons, Inc. — Product Code CDX

K770726 is an FDA 510(k) premarket notification submitted by Squibb & Sons, Inc. for the device "RIA KIT, T4 CLASP". The FDA issued a decision of Substantially Equivalent on April 28, 1977. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Squibb & Sons, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1977
Date Received
April 19, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

Other clearances by Squibb & Sons, Inc.

  • K821174 — TSH-SQUIBB RADIOIMMUNOASSAY KIT (May 14, 1982)
  • K801424 — ESTRIOL RIA KIT FOR USE WITH GAMMAFLO (July 21, 1980)
  • K800750 — STOMAHESIVE STERILE WAFER (May 8, 1980)
  • K761267 — ANGIOTENSIN I IMMUTOPE KIT (December 30, 1976)

Other clearances for product code CDX

  • K961490 — ELECSYS T4 ASSAY (June 13, 1996)
  • K954312 — ACTIVE THYROXINE RIA (October 7, 1995)
  • K943416 — DELFIA NEONATAL THYROXINE KIT (March 10, 1995)
  • K934384 — AXSYM(TM) TOTAL T4 (June 21, 1994)
  • K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (October 18, 1993)
  • K933426 — STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (August 26, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K925110 — ABBOTT IMX T4 (January 26, 1993)
  • K925109 — ABBOTT TDX/TDXFLX TT4 (January 4, 1993)

FDA data resources