510(k) K820149
K820149 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "PYR BROTH". The FDA issued a decision of Substantially Equivalent on Feb 5, 1982. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Carr-Scarborough Microbiologicals, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 5, 1982
- Date Received
- Jan 19, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Single Biochemical Test
- Device Class
- Class I
- Regulation Number
- 866.2320
- Review Panel
- MI
- Submission Type
- 510(k) Exempt