510(k) K853896
K853896 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "GRAM STAIN KIT". The FDA issued a decision of Substantially Equivalent on Oct 22, 1985. The device falls under product code JTS (Stains, Microbiologic), a Class I device regulated under 21 CFR 864.1850. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 22, 1985
- Date Received
- Sep 20, 1985
- 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