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510(k) K861703

LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) by Leeco Diagnostics, Inc. — Product Code JHJ

K861703 is an FDA 510(k) premarket notification submitted by Leeco Diagnostics, Inc. for the device "LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)". The FDA issued a decision of Substantially Equivalent on July 29, 1986. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Leeco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1986
Date Received
May 5, 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 Leeco Diagnostics, Inc.

  • K895765 — LEECO PREVIEW(R) EBV (EIA) (October 31, 1989)
  • K894122 — LEECO VIS-DISK STREP-A (EIA) (August 15, 1989)
  • K891096 — VIS-DISK HCG (EIA) JPL-041M (June 16, 1989)
  • K891095 — VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M (June 16, 1989)
  • K883269 — PRL-QUANT (September 13, 1988)
  • K880577 — CONCEP-7-BHCG (March 15, 1988)
  • K880069 — LEECO PREGNASTICK (EIA) CATALOG #003 (February 11, 1988)
  • K870259 — VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 (March 10, 1987)
  • K864170 — LEECO VIS-CUBE STREP A (EIA) (February 3, 1987)
  • K863999 — VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 (January 9, 1987)

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