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510(k) K832527

PREGNA-TEC by Medilab Corp. — Product Code JHJ

K832527 is an FDA 510(k) premarket notification submitted by Medilab Corp. for the device "PREGNA-TEC". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Medilab Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 29, 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 Medilab Corp.

  • K841862 — IMMU-TEC (June 13, 1984)
  • K841863 — MONO-TEC (June 13, 1984)
  • K840291 — MCS ALBUMIN REAGENT (March 30, 1984)
  • K840290 — MCS TOTAL PROTEIN REAGENT (March 30, 1984)
  • K840289 — LYSE-TEC (March 5, 1984)
  • K832918 — PREGNA-TEC (November 3, 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