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510(k) K831504

HERPES IDENT. & TYPING TEST HITT by Electro-Nucleonics Laboratories, Inc. — Product Code GQL

K831504 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics Laboratories, Inc. for the device "HERPES IDENT. & TYPING TEST HITT". The FDA issued a decision of Substantially Equivalent on September 20, 1983. The device falls under product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Electro-Nucleonics Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1983
Date Received
May 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Electro-Nucleonics Laboratories, Inc.

  • K873925 — VIRGO(TM) MEASLES IGG ELISA (February 24, 1988)
  • K873617 — GEMSTAR II SYSTEM (October 19, 1987)
  • K873416 — MULTI-ACCESS REAGENT DISPENSER (October 9, 1987)
  • K873358 — GEMENI URIC ACID U.V. (September 11, 1987)
  • K873088 — VIRGO(TM) RUBELLA IGG ELISA (September 9, 1987)
  • K871905 — TOXOPLASMA GONDII IGG ELISA (July 30, 1987)
  • K870928 — CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS (April 22, 1987)
  • K863874 — LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES (November 13, 1986)
  • K862640 — AMYLASE LTS (September 9, 1986)
  • K853372 — GEMSTAR IPA THEOPHYLLINE TEST KIT (September 4, 1985)

Other clearances for product code GQL

  • K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM (August 28, 2009)
  • K081527 — LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT (April 1, 2009)
  • K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME L (May 26, 1999)
  • K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME (May 26, 1999)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
  • K904095 — HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (February 1, 1991)
  • K904167 — PATHODX HERPES TYPING (December 13, 1990)
  • K902662 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST (July 31, 1990)
  • K902661 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 (July 31, 1990)
  • K891782 — HSV-2 ELISA TEST SYSTEM (June 20, 1989)

FDA data resources