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510(k) K800297

SANDARE FAST 340 PHOSPHOROUS PROCEDURE by Sandare Chemical Co., Inc. — Product Code CEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1980
Date Received
February 11, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device Class
Class I
Regulation Number
862.1580
Review Panel
CH
Submission Type

Other clearances by Sandare Chemical Co., Inc.

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  • K860684 — SANDARE BCG ALBUMIN PROCEDURE (March 17, 1986)
  • K851395 — SANDARE IRON-BINDING CAPACITY PROCEDURE (May 7, 1985)
  • K851394 — SANDARE IRON PROCEDURE (April 30, 1985)
  • K844498 — SANDARE ALKALINE PHOSPHATASE PROCEDURE (December 10, 1984)
  • K842516 — SANDARE ACID PHOSPHATASE PROCEDURE (August 17, 1984)
  • K833898 — TRI-LEVEL BILIRUBIN CONTROLS (January 13, 1984)
  • K832942 — TOTAL & DIRECT BILIRUBIN PROCEDURES (November 7, 1983)
  • K832632 — ALBUMIN PROCEDURE BCP (September 12, 1983)

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