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510(k) K800672

SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC by Diagnostic Solutions, Inc. — Product Code CDH

K800672 is an FDA 510(k) premarket notification submitted by Diagnostic Solutions, Inc. for the device "SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code CDH (Acid, Uric, Phosphotungstate Reduction), a Class I device regulated under 21 CFR 862.1775. Diagnostic Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
March 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Phosphotungstate Reduction
Device Class
Class I
Regulation Number
862.1775
Review Panel
CH
Submission Type

Other clearances by Diagnostic Solutions, Inc.

  • K934892 — RELIEF PLUS ONE REAGENT STRIP MODIFICATION (January 11, 1994)
  • K924398 — UNI-CHECK REAGENT STRIP (December 23, 1992)
  • K921825 — QUICK-CHECK II REAGENT STRIP (August 18, 1992)
  • K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (May 30, 1980)
  • K800689 — REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- (May 30, 1980)
  • K800678 — REAGENTS FOR DETERM. ALBUMIN IN HUMAN (May 28, 1980)
  • K800677 — REAGENTS FOR DETERM. SERUM IRON IN HUMAN (May 28, 1980)
  • K800675 — REAGENTS FOR DETERM. TOTAL BILIRUBIN (May 28, 1980)
  • K800685 — REAGENT FOR DETERM. CREATININE IN H/SERU (May 28, 1980)
  • K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM (May 28, 1980)

Other clearances for product code CDH

  • K850933 — URIC ACID (June 25, 1985)
  • K841067 — URIC ACID REAGENT SET (May 1, 1984)
  • K821213 — URIC ACID REAGENT SET (July 13, 1982)
  • K813076 — PHOSPHOTUNGSTATE REDUCTION, URIC ACID (November 16, 1981)
  • K810088 — URIC ACID (TPTZ) COLORINMETRIC (January 28, 1981)
  • K800190 — STANBIO DIRECT URIC ACID TEST SET #0770 (February 13, 1980)
  • K792412 — ELVI URIC ACID (December 7, 1979)
  • K792403 — ELVI URIC ACID-COLORIMETRIC METHOD (December 7, 1979)
  • K790019 — SERUM, URIC ACID DETERMINATION (February 26, 1979)
  • K772082 — ENZAC URIC ACID 100-TEST KIT (November 28, 1977)

FDA data resources