COUNTER, RACK GAMMA (#1270)

Counter (beta, Gamma) For Clinical Use

LKB INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Counter, Rack Gamma (#1270).

Pre-market Notification Details

Device IDK760470
510k NumberK760470
Device Name:COUNTER, RACK GAMMA (#1270)
ClassificationCounter (beta, Gamma) For Clinical Use
Applicant LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJJ  
CFR Regulation Number862.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-08-19
Decision Date1976-11-01

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