510(k) K771838
K771838 is an FDA 510(k) premarket notification submitted by Gamma Enterprises, Inc. for the device "SERUM IRON". The FDA issued a decision of Substantially Equivalent on November 3, 1977. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Gamma Enterprises, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1977
- Date Received
- September 21, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photometric Method, Iron (Non-Heme)
- Device Class
- Class I
- Regulation Number
- 862.1410
- Review Panel
- CH
- Submission Type