510(k) K820347
K820347 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "ACCU-STAPH". The FDA issued a decision of Substantially Equivalent on Mar 4, 1982. The device falls under product code LHT (Staphylococcus Aureus Somatic Antigens), a Class I device regulated under 21 CFR 866.3700. Carr-Scarborough Microbiologicals, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 4, 1982
- Date Received
- Feb 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Staphylococcus Aureus Somatic Antigens
- Device Class
- Class I
- Regulation Number
- 866.3700
- Review Panel
- MI
- Submission Type
- 510(k) Exempt