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510(k) K811864

SIGMA PROCEDURE 265-UV by Sigma Chemical Co. — Product Code CED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1981
Date Received
July 1, 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

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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)
  • K811222 — INORGANIC PHOSPHORUS REAGENTS (May 21, 1981)
  • K802420 — CENTRIFICHEM INORGANIC PHOSPHORUS (October 31, 1980)
  • K790662 — CENTRIFICHEM INORGANIC PHOSPHORUS (May 15, 1979)