510(k) K812212
K812212 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "ACRIDINE ORANGE STAIN". The FDA issued a decision of Substantially Equivalent on Sep 1, 1981. The device falls under product code IDC (Acridine Orange), 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 5, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Acridine Orange
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type
- 510(k) Exempt