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510(k) K802420

CENTRIFICHEM INORGANIC PHOSPHORUS by Union Carbide Corp. — Product Code CED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 6, 1980
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

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  • K802741 — CENTRIFICHEM COMB. SERUM-BASED CALIB. (December 10, 1980)
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Other clearances for product code CED

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  • K820832 — PHOSPHORUS IL (April 15, 1982)
  • K812670 — SANDARE FAST 340 PHOSPHORUS PROCEDURE (October 2, 1981)
  • K811864 — SIGMA PROCEDURE 265-UV (July 31, 1981)
  • K811222 — INORGANIC PHOSPHORUS REAGENTS (May 21, 1981)
  • K790662 — CENTRIFICHEM INORGANIC PHOSPHORUS (May 15, 1979)