510(k) K864033
K864033 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "RAPID ACID FAST STAIN". The FDA issued a decision of Substantially Equivalent on Nov 13, 1986. The device falls under product code KJY (Malachite Green), 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
- Nov 13, 1986
- Date Received
- Oct 15, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Malachite Green
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type
- 510(k) Exempt