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510(k) K791309

UCG-LYPHOTEST by Wampole Laboratories — Product Code JHJ

K791309 is an FDA 510(k) premarket notification submitted by Wampole Laboratories for the device "UCG-LYPHOTEST". The FDA issued a decision of Substantially Equivalent on July 30, 1979. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Wampole Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1979
Date Received
July 16, 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 Wampole Laboratories

  • K965129 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (March 26, 1997)
  • K965131 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (March 26, 1997)
  • K911444 — RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM (August 30, 1991)
  • K882896 — ONE-STEP HCG (October 31, 1988)
  • K883004 — MONO-PLUS(TM) (August 4, 1988)
  • K875101 — VIROGEN CMV ANTIBODY TEST (March 1, 1988)
  • K875161 — MAT (TM) MICROALBUMIN TEST (February 17, 1988)
  • K790986 — RF CONTROLS (June 28, 1979)
  • K781794 — BETA-TEC (December 29, 1978)
  • K760336 — BIOCEPT-G (November 12, 1976)

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