510(k) K881104
K881104 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PARAMAX IRON REAGENT". The FDA issued a decision of Substantially Equivalent on Apr 28, 1988. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 28, 1988
- Date Received
- Mar 15, 1988
- 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
- 510(k) Exempt