510(k) K812668
K812668 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "AFB STAIN SET". The FDA issued a decision of Substantially Equivalent on Sep 29, 1981. The device falls under product code JTS (Stains, Microbiologic), a Class I device regulated under 21 CFR 864.1850. Carr-Scarborough Microbiologicals, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 29, 1981
- Date Received
- Sep 21, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stains, Microbiologic
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- MI
- Submission Type
- 510(k) Exempt