510(k) K782159
K782159 is an FDA 510(k) premarket notification submitted by Leeco Diagnostics, Inc. for the device "DIAGNOSTIC KIT, FERRITAB-FE-59". The FDA issued a decision of Substantially Equivalent on February 1, 1979. The device falls under product code JJA (Radio-Labeled Iron Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Leeco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1979
- Date Received
- December 22, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radio-Labeled Iron Method, Iron (Non-Heme)
- Device Class
- Class I
- Regulation Number
- 862.1410
- Review Panel
- CH
- Submission Type