510(k) K834007

CYSTINE TRYPTIC MEDIUM by Micro Media Laboratories — Product Code JSQ

K834007 is an FDA 510(k) premarket notification submitted by Micro Media Laboratories for the device "CYSTINE TRYPTIC MEDIUM". The FDA issued a decision of Substantially Equivalent on December 22, 1983. The device falls under product code JSQ (Chromatography For Bacterial Identification), a Class I device regulated under 21 CFR 862.2250. Micro Media Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1983
Date Received
November 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography For Bacterial Identification
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
Submission Type