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510(k) K862044

DELFIA (TM) HCG KIT by Lkb Instruments, Inc. — Product Code JHJ

K862044 is an FDA 510(k) premarket notification submitted by Lkb Instruments, Inc. for the device "DELFIA (TM) HCG KIT". The FDA issued a decision of Substantially Equivalent on July 11, 1986. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Lkb Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1986
Date Received
May 28, 1986
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 Lkb Instruments, Inc.

  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 1987)
  • K872955 — DELFIA(TM) FERRITIN KIT (August 21, 1987)
  • K871303 — DELFIA(TM) THYROXINE (T4) KIT (June 17, 1987)
  • K871599 — DELFIA(TM) HIGE KIT (June 12, 1987)
  • K871644 — DELFIA (TM) HTSH KIT (May 12, 1987)
  • K864452 — DELFIA(TM) TRIIODOTHYRONINE (T3) KIT (February 2, 1987)
  • K864733 — LKB 2260 MACROTOME (January 5, 1987)
  • K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (December 18, 1986)
  • K863422 — DELFIA(TM) CORTISOL KIT (September 26, 1986)
  • K861195 — DELFIA DIGOXIN (July 11, 1986)

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