Electro-Nucleonics Laboratories, Inc. - FDA 510(k) Cleared Devices
Recent clearances: VIRGO(TM) MEASLES IGG ELISA, GEMSTAR II SYSTEM, MULTI-ACCESS REAGENT DISPENSER
41
Total
41
Cleared
0
Denied
FDA 510(k) Regulatory Record - Electro-Nucleonics Laboratories, Inc. Chemistry ✕
18 devices
Cleared
Oct 19, 1987
GEMSTAR II SYSTEM
Chemistry
41d
Cleared
Oct 09, 1987
MULTI-ACCESS REAGENT DISPENSER
Chemistry
45d
Cleared
Sep 11, 1987
GEMENI URIC ACID U.V.
Chemistry
21d
Cleared
Apr 22, 1987
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
Chemistry
44d
Cleared
Nov 13, 1986
LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES
Chemistry
41d
Cleared
Sep 09, 1986
AMYLASE LTS
Chemistry
61d
Cleared
Aug 23, 1985
DELTA TROL I & II
Chemistry
11d
Cleared
Apr 29, 1985
GEMENI AST-LTS REAGENTS
Chemistry
31d
Cleared
Jan 03, 1985
AUTOLOADER II
Chemistry
100d
Cleared
Nov 27, 1984
ENI BLOOD UREA NITROGEN REAGENT
Chemistry
40d
Cleared
Nov 03, 1983
STARLYTE
Chemistry
80d
Cleared
Sep 20, 1983
ACCLAIM
Chemistry
46d
Cleared
Sep 12, 1983
CREATINE KINASE REAGENT CK LTS
Chemistry
84d
Cleared
Sep 12, 1983
ALT -LTS
Chemistry
39d
Cleared
Jul 13, 1982
GEMSTAR SYSTEM
Chemistry
69d
Cleared
Jun 18, 1981
FLEXIGRAM AUTO LOADER SYSTEM
Chemistry
20d
Cleared
May 28, 1980
RIAUSE AUTO PROCESSOR
Chemistry
27d
Cleared
Dec 29, 1976
GEMENI GPT (ALT) ASSAY
Chemistry
13d