510(k) K812212

ACRIDINE ORANGE STAIN by Carr-Scarborough Microbiologicals, Inc. — Product Code IDC

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 September 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1981
Date Received
August 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