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510(k) K810514

SANDARE NITROPRUSSIDE TEST PROCEDURE by Sandare Chemical Co., Inc. — Product Code JLC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1981
Date Received
February 25, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitroprusside Reaction (Qualitative, Urine), Cystine
Device Class
Class I
Regulation Number
862.1240
Review Panel
CH
Submission Type

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  • K833898 — TRI-LEVEL BILIRUBIN CONTROLS (January 13, 1984)
  • K832942 — TOTAL & DIRECT BILIRUBIN PROCEDURES (November 7, 1983)
  • K832632 — ALBUMIN PROCEDURE BCP (September 12, 1983)

Other clearances for product code JLC

  • K843382 — UROCYSTIN (January 8, 1985)