510(k) K871544
K871544 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "METHYL GREEN SOLUTION". The FDA issued a decision of Substantially Equivalent on Apr 29, 1987. The device falls under product code HZA (Methyl 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
- Apr 29, 1987
- Date Received
- Apr 14, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Methyl Green
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type
- 510(k) Exempt