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510(k) K831125

BTC URINE LCG ASSAY by Btc Diagnostics, Inc. — Product Code JHJ

K831125 is an FDA 510(k) premarket notification submitted by Btc Diagnostics, Inc. for the device "BTC URINE LCG ASSAY". The FDA issued a decision of Substantially Equivalent on May 5, 1983. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Btc Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1983
Date Received
April 5, 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 Btc Diagnostics, Inc.

  • K841545 — ENZYME IMMUNOASSAY FOR DETECTION HORM (November 27, 1984)
  • K832905 — QUALITATIVE ENZYME IMMUNOASSAY-DETECT (February 3, 1984)
  • K833710 — BTC URINE LH ASSAY (January 30, 1984)
  • K831604 — HCG ACCU-STICK (July 19, 1983)

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