510(k) K920975
K920975 is an FDA 510(k) premarket notification submitted by Remel Co. for the device "BACTIDROP CALCOFLUOR WHITE". The FDA issued a decision of Substantially Equivalent on Jun 9, 1992. The device falls under product code JTS (Stains, Microbiologic), a Class I device regulated under 21 CFR 864.1850. Remel Co. has 153 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 9, 1992
- Date Received
- Mar 2, 1992
- 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