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510(k) K822826

ANTIBODY TO MUMPS VIRUS IFA TEST by Electro-Nucleonics Laboratories, Inc. — Product Code GRA

K822826 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics Laboratories, Inc. for the device "ANTIBODY TO MUMPS VIRUS IFA TEST". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code GRA (Antiserum, Fluorescent, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Electro-Nucleonics Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
September 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Mumps Virus
Device Class
Class I
Regulation Number
866.3380
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 GRA

  • K894624 — MUMPS VIRUS (October 16, 1989)
  • K770216 — VIRAL ANTISERA, FLUORESCEIN LABELED (March 1, 1977)

FDA data resources