510(k) K820563
K820563 is an FDA 510(k) premarket notification submitted by American Laboratory Supply, Inc. for the device "THIOGLYCOLLATE ENRICHED". The FDA issued a decision of Substantially Equivalent on Mar 16, 1982. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. American Laboratory Supply, Inc. has 35 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 16, 1982
- Date Received
- Mar 2, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Enriched
- Device Class
- Class I
- Regulation Number
- 866.2330
- Review Panel
- MI
- Submission Type
- 510(k) Exempt