510(k) K811138
K811138 is an FDA 510(k) premarket notification submitted by Acumedia Manufacturers, Inc. for the device "NUTRIENT AGAR". The FDA issued a decision of Substantially Equivalent on May 5, 1981. The device falls under product code JSQ (Chromatography For Bacterial Identification), a Class I device regulated under 21 CFR 862.2250. Acumedia Manufacturers, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 1981
- Date Received
- April 24, 1981
- 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