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510(k) K953084

ACCESS ULTRASENSITIVE INSULIN ASSAY by Bio-Rad Laboratories, Inc. — Product Code CFP

K953084 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "ACCESS ULTRASENSITIVE INSULIN ASSAY". The FDA issued a decision of Substantially Equivalent on September 25, 1995. The device falls under product code CFP (Radioimmunoassay, Immunoreactive Insulin), a Class I device regulated under 21 CFR 862.1405. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1995
Date Received
July 3, 1995
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

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Other clearances for product code CFP

  • K963911 — ALPCO/MERCODIA INSULIN ELISA (November 1, 1996)
  • 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)
  • K823939 — WAKO INSULIN TEST (January 28, 1983)

FDA data resources