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510(k) K791609

BE-SURE by Biologics Intl., Inc. — Product Code JHJ

K791609 is an FDA 510(k) premarket notification submitted by Biologics Intl., Inc. for the device "BE-SURE". The FDA issued a decision of Substantially Equivalent on October 2, 1979. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Biologics Intl., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1979
Date Received
August 10, 1979
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 Biologics Intl., Inc.

  • K882229 — AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS (August 16, 1988)
  • K823353 — CARCINO-CEK (December 14, 1982)
  • K812060 — BI-ASO SLIDE TEST (August 13, 1981)
  • K811374 — BI-CRP LATEX TEST (June 12, 1981)
  • K811375 — BI-RA SLIDE TEST (June 12, 1981)
  • K800605 — ANA LATEX SLIDE TEST (April 2, 1980)
  • K791607 — BETA-CELL (September 24, 1979)
  • K790898 — PREG-TEX (July 30, 1979)

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