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510(k) K853372

GEMSTAR IPA THEOPHYLLINE TEST KIT by Electro-Nucleonics Laboratories, Inc. — Product Code KLS

K853372 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics Laboratories, Inc. for the device "GEMSTAR IPA THEOPHYLLINE TEST KIT". The FDA issued a decision of Substantially Equivalent on September 4, 1985. The device falls under product code KLS (Enzyme Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Electro-Nucleonics Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1985
Date Received
August 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
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)
  • K853373 — DELTA TROL I & II (August 23, 1985)

Other clearances for product code KLS

  • K042520 — VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II (November 30, 2004)
  • K042407 — EMIT CAFFEINE ASSAY (October 28, 2004)
  • K020740 — ROCHE ONLINE THEOPHYLLINE (April 16, 2002)
  • K011771 — RANDOX THEOPHYLLINE (January 17, 2002)
  • K013272 — ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY (October 25, 2001)
  • K011166 — MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 (May 10, 2001)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K973583 — ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (November 12, 1997)
  • K972495 — ACCUMETER THEOPHYLLINE TEST (October 10, 1997)
  • K961462 — CEDIA THEOPHYLLINE ASSAY (June 27, 1996)

FDA data resources