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510(k) K831180

PREGNA-CERT, SLIDE PREGNANCY TEST by Diagnostic Specialties — Product Code JHJ

K831180 is an FDA 510(k) premarket notification submitted by Diagnostic Specialties for the device "PREGNA-CERT, SLIDE PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on May 27, 1983. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Diagnostic Specialties has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1983
Date Received
April 11, 1983
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 Diagnostic Specialties

  • K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (September 2, 1997)
  • K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (August 30, 1994)
  • K930823 — PROTEIN-BOUND GLUCOSE ASSAYN KIT (August 19, 1993)
  • K922032 — ENZIP URINARY MICROALBUMIN TEST (July 30, 1992)
  • K823109 — GENERIC PREGNANCY TEST (November 10, 1982)
  • K813608 — POTASSIUM REAGENT SET (January 22, 1982)
  • K813412 — GLUCOSE ENZYME-COLOR REAGENT SET (December 31, 1981)

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