510(k) K821864
K821864 is an FDA 510(k) premarket notification submitted by Granite Diagnostics, Inc. for the device "THIOGLYCOLLATE MED. W/VITAMIN K-1". The FDA issued a decision of Substantially Equivalent on July 13, 1982. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. Granite Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1982
- Date Received
- June 24, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, General Nutrient Broth
- Device Class
- Class I
- Regulation Number
- 866.2350
- Review Panel
- MI
- Submission Type