510(k) K834007
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