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510(k) K852286

DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST by Sero-Immuno Diagnostics, Inc. — Product Code JHJ

K852286 is an FDA 510(k) premarket notification submitted by Sero-Immuno Diagnostics, Inc. for the device "DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on July 9, 1985. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Sero-Immuno Diagnostics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1985
Date Received
May 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agglutination Method, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Sero-Immuno Diagnostics, Inc.

  • K842181 — BETA-HCG HEMAGGLUTINATION TEST (August 22, 1984)
  • K834328 — DAT TEST FOR CHAGAS' DISEASE (March 2, 1984)

Other clearances for product code JHJ

  • K972606 — PREGNACOL PREGNANCY TEST (August 29, 1997)
  • K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (June 28, 1996)
  • K935863 — SAS(TM) DIRECT MONOCLONAL HCG (February 24, 1994)
  • K926112 — ACCUTEX BETA-HCG TEST (July 28, 1993)
  • K930609 — SAS(TM) MONOCLONAL HCG-SLIDE (March 29, 1993)
  • K920716 — DIRECT PREGNANCY TEST (March 24, 1992)
  • K910946 — CLEARVIEW HCG (April 1, 1991)
  • K881435 — PREGNOSPIA II (May 27, 1988)
  • K880163 — PREGNANCY (HCG) CARD & LIQUID TEST (May 17, 1988)
  • K880478 — PREGNANCY BETA-HCG CARD & LIQUID TEST (April 28, 1988)

FDA data resources