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Electro-Nucleonics Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
41
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K873925VIRGO(TM) MEASLES IGG ELISAFebruary 24, 1988
K873617GEMSTAR II SYSTEMOctober 19, 1987
K873416MULTI-ACCESS REAGENT DISPENSEROctober 9, 1987
K873358GEMENI URIC ACID U.V.September 11, 1987
K873088VIRGO(TM) RUBELLA IGG ELISASeptember 9, 1987
K871905TOXOPLASMA GONDII IGG ELISAJuly 30, 1987
K870928CHOLESTEROL (TOTAL) ANALYSIS PRODUCTSApril 22, 1987
K863874LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDESNovember 13, 1986
K862640AMYLASE LTSSeptember 9, 1986
K853372GEMSTAR IPA THEOPHYLLINE TEST KITSeptember 4, 1985
K853373DELTA TROL I & IIAugust 23, 1985
K851267GEMENI AST-LTS REAGENTSApril 29, 1985
K843779AUTOLOADER IIJanuary 3, 1985
K844065ENI BLOOD UREA NITROGEN REAGENTNovember 27, 1984
K841127VIRGO REAGENTS INDIRECT FLUORSCENTApril 25, 1984
K832744STARLYTENovember 3, 1983
K832648ACCLAIMSeptember 20, 1983
K831504HERPES IDENT. & TYPING TEST HITTSeptember 20, 1983
K831965CREATINE KINASE REAGENT CK LTSSeptember 12, 1983
K832639ALT -LTSSeptember 12, 1983