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510(k) K790630

RIA, INSULIN, DOUBLE ANTIBODY by Endocrine-Metabolic Center — Product Code CFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1979
Date Received
March 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Immunoreactive Insulin
Device Class
Class I
Regulation Number
862.1405
Review Panel
CH
Submission Type

Other clearances by Endocrine-Metabolic Center

  • K821131 — RADIOIMMUNOASSAY PARATHYROID HORMONE MID (June 2, 1982)
  • K811993 — RADIOIMMUNOASSAY, FOLLICLE STIMULATING (August 3, 1981)
  • K811994 — RADIOIMMUNOASSAY LUTEINIZING HORMONE (July 27, 1981)
  • K810948 — RADIOIMMUNOASSAY THYROID STIM. HORM. KIT (April 17, 1981)
  • K810351 — RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE (February 23, 1981)
  • K800187 — EMC-M-175, THYROXINE - 100 TUBES (February 13, 1980)
  • K800188 — EMC-M-180, T3 UPTAKE - 100 TUBES (February 13, 1980)
  • K790602 — RIA, DIGNXIN-125-I (July 30, 1979)

Other clearances for product code CFP

  • K963911 — ALPCO/MERCODIA INSULIN ELISA (November 1, 1996)
  • K953084 — ACCESS ULTRASENSITIVE INSULIN ASSAY (September 25, 1995)
  • K920109 — IMX INSULIN (May 7, 1992)
  • K914820 — DSL INSULIN RIA (DSL 1600) (January 9, 1992)
  • K903628 — AIA-PACK IRI (September 7, 1990)
  • K901135 — ENZYMUN TEST(R) INSULIN (April 3, 1990)
  • K896572 — REP(TM) SPE PLUS-30 PROCEDURES (January 11, 1990)
  • K890837 — RIA-GNOST INSULIN (April 26, 1989)
  • K851071 — PHARMACIA INSULIN RIA (April 12, 1985)
  • K841573 — INSULIN RADIOIMMUNOASSAY KIT (May 16, 1984)