510(k) K811222
K811222 is an FDA 510(k) premarket notification submitted by Connecticut Diagnostics, Ltd. for the device "INORGANIC PHOSPHORUS REAGENTS". The FDA issued a decision of Substantially Equivalent on May 21, 1981. The device falls under product code CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase), a Class I device regulated under 21 CFR 862.1520. Connecticut Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1981
- Date Received
- May 4, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- Device Class
- Class I
- Regulation Number
- 862.1520
- Review Panel
- CH
- Submission Type