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510(k) K761267

ANGIOTENSIN I IMMUTOPE KIT by Squibb & Sons, Inc. — Product Code CIB

K761267 is an FDA 510(k) premarket notification submitted by Squibb & Sons, Inc. for the device "ANGIOTENSIN I IMMUTOPE KIT". The FDA issued a decision of Substantially Equivalent on December 30, 1976. The device falls under product code CIB (Radioimmunoassay, Angiotensin I And Renin), a Class II device regulated under 21 CFR 862.1085. Squibb & Sons, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1976
Date Received
December 16, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Angiotensin I And Renin
Device Class
Class II
Regulation Number
862.1085
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)
  • K770726 — RIA KIT, T4 CLASP (April 28, 1977)

Other clearances for product code CIB

  • K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIR (December 24, 2013)
  • K121944 — LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT (January 1, 2013)
  • K062120 — CISBIO RENIN RIA TEST (March 30, 2007)
  • K061758 — ACTIVE RENIN IRMA (July 28, 2006)
  • K011128 — NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AN (September 6, 2001)
  • K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (May 27, 1998)
  • K954299 — BUHLMANN ANGIOSTENSIN II RIA (October 19, 1995)
  • K940004 — AI-PHOTODIAGNOSTIC (August 4, 1995)
  • K925998 — ACTIVE RENIN IMMUNORADIOMETRIC ASSAY (January 6, 1993)
  • K850054 — RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI (March 29, 1985)

FDA data resources