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510(k) K811423

VENTRE/SEP by Ventrex Laboratories, Inc. — Product Code CFP

K811423 is an FDA 510(k) premarket notification submitted by Ventrex Laboratories, Inc. for the device "VENTRE/SEP". The FDA issued a decision of Substantially Equivalent on June 9, 1981. The device falls under product code CFP (Radioimmunoassay, Immunoreactive Insulin), a Class I device regulated under 21 CFR 862.1405. Ventrex Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1981
Date Received
May 21, 1981
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 Ventrex Laboratories, Inc.

  • K914554 — SPECIFIC IGE EIA-TURBO ASSAY (March 13, 1992)
  • K913833 — VENTREX ALLERGEN DISC (February 21, 1992)
  • K913434 — VENTREX COATED TUBE INTACT PTH (October 25, 1991)
  • K905612 — VENTREX COATED TUBE IGE RADIOIMMUNOASSAY (February 21, 1991)
  • K905636 — VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY (February 7, 1991)
  • K905247 — SHBG IRMA KIT (January 17, 1991)
  • K904330 — TURBO-RAST SPECIFIC IGE ASSAY (December 7, 1990)
  • K903000 — TURBO-RAST SPECIFIC IGE ASSAY (July 31, 1990)
  • K897083 — VENTRESIGN STREP A TEST (January 22, 1990)
  • K895649 — COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. (January 18, 1990)

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)

FDA data resources