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510(k) K810514

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

K810514 is an FDA 510(k) premarket notification submitted by Sandare Chemical Co., Inc. for the device "SANDARE NITROPRUSSIDE TEST PROCEDURE". The FDA issued a decision of Substantially Equivalent on March 4, 1981. The device falls under product code JLC (Nitroprusside Reaction (Qualitative, Urine), Cystine), a Class I device regulated under 21 CFR 862.1240. Sandare Chemical Co., Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Sandare Chemical Co., Inc.

  • K872852 — EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST (September 29, 1987)
  • K862556 — SANDARE GLYCOHEMOGLOBIN PROCEDURE (August 8, 1986)
  • 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)

Other clearances for product code JLC

  • K843382 — UROCYSTIN (January 8, 1985)

FDA data resources