510(k) K821977
K821977 is an FDA 510(k) premarket notification submitted by Granite Diagnostics, Inc. for the device "GRAMSTAIN SET". The FDA issued a decision of Substantially Equivalent on Jul 22, 1982. The device falls under product code HYI (Iodine, Grams), a Class I device regulated under 21 CFR 864.1850. Granite Diagnostics, Inc. has 46 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 1982
- Date Received
- Jul 6, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Iodine, Grams
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type
- 510(k) Exempt