510(k) K812274
K812274 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "AURAMINE O MYCROBACTERIAL STAIN SET". The FDA issued a decision of Substantially Equivalent on Sep 1, 1981. The device falls under product code KJK (Auramine O), 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 1, 1981
- Date Received
- Aug 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Auramine O
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type
- 510(k) Exempt