Home / 510(k) Clearances / K831468

510(k) K831468

B HCG-CHECK by Diagnostic Technology, Inc. — Product Code JHJ

K831468 is an FDA 510(k) premarket notification submitted by Diagnostic Technology, Inc. for the device "B HCG-CHECK". The FDA issued a decision of Substantially Equivalent on June 22, 1983. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Diagnostic Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1983
Date Received
May 6, 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 Diagnostic Technology, Inc.

  • K896378 — LYME-CHECK(TM) TEST KIT (November 5, 1991)
  • K903612 — EBV/EA-CHECK TM TEST KIT (October 16, 1990)
  • K890819 — HSV-CHECK(TM) TEST KIT (June 20, 1989)
  • K890639 — RESUBMITTED EBV/IGM-CHECK TEST KIT (June 20, 1989)
  • K891542 — EBNA-CHECK(TM) TEST KIT (June 20, 1989)
  • K871373 — EBV-CHECK(TM) TEST KIT (IGG) (June 25, 1987)
  • K864128 — CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (April 29, 1987)
  • K863408 — EBV/VCA-CHECK(TM) ANTIGEN SLIDES (November 28, 1986)
  • K860586 — PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS (May 7, 1986)
  • K860166 — PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 (April 4, 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