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510(k) K821249

ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS by Electro-Nucleonics Laboratories, Inc. — Product Code GRE

K821249 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics Laboratories, Inc. for the device "ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS". The FDA issued a decision of Substantially Equivalent on July 30, 1982. The device falls under product code GRE (Antiserum, Fluorescent, Rubeola), a Class I device regulated under 21 CFR 866.3520. Electro-Nucleonics Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1982
Date Received
April 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Rubeola
Device Class
Class I
Regulation Number
866.3520
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 GRE

  • K884004 — RUBEOLA TEST (December 5, 1988)
  • K853067 — FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT (October 22, 1985)
  • K770687 — MEASLESVIRUS FLOURE. CONJUGATED ANTISERU (June 14, 1977)

FDA data resources