510(k) K934588
K934588 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals , Ltd. for the device "CHLORIDE (MF) ASSAY". The FDA issued a decision of Substantially Equivalent on February 18, 1994. The device falls under product code CHG (Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride), a Class II device regulated under 21 CFR 862.1170. Diagnostic Chemicals , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1994
- Date Received
- September 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
- Device Class
- Class II
- Regulation Number
- 862.1170
- Review Panel
- CH
- Submission Type