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510(k) K903000

TURBO-RAST SPECIFIC IGE ASSAY by Ventrex Laboratories, Inc. — Product Code JHR

K903000 is an FDA 510(k) premarket notification submitted by Ventrex Laboratories, Inc. for the device "TURBO-RAST SPECIFIC IGE ASSAY". The FDA issued a decision of Substantially Equivalent on July 31, 1990. The device falls under product code JHR (Radioimmunoassay, Immunoglobulins (D, E)), a Class II device regulated under 21 CFR 866.5510. Ventrex Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1990
Date Received
July 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Immunoglobulins (D, E)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
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)
  • K897083 — VENTRESIGN STREP A TEST (January 22, 1990)
  • K895649 — COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. (January 18, 1990)
  • K895648 — COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. (January 18, 1990)

Other clearances for product code JHR

  • K061970 — ELECSYS IGE II IMMUNOASSAY (August 31, 2006)
  • K984326 — ELECYS IGE ASSAY (February 8, 1999)
  • K960067 — IMMILITE TOTAL IGE (February 14, 1996)
  • K931703 — IMMULITE TOTAL IGE (August 16, 1993)
  • K901859 — COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 (May 3, 1990)
  • K882616 — ALTERNATE PROCEDURE, PHARMACIA IGE EIA (August 4, 1988)
  • K873077 — PHARMACIA IGE EIA (October 20, 1987)
  • K840103 — RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN (February 10, 1984)

FDA data resources