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510(k) K841067

URIC ACID REAGENT SET by Medical Specialties, Inc. — Product Code CDH

K841067 is an FDA 510(k) premarket notification submitted by Medical Specialties, Inc. for the device "URIC ACID REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 1, 1984. The device falls under product code CDH (Acid, Uric, Phosphotungstate Reduction), a Class I device regulated under 21 CFR 862.1775. Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1984
Date Received
March 12, 1984
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 Medical Specialties, Inc.

  • K946201 — STAND, INFUSION (April 18, 1995)
  • K931947 — CHECKPOINT (June 18, 1993)
  • K926095 — REFRACTROL-SP (January 26, 1993)
  • K924926 — MSI-HCT (January 7, 1993)
  • K896566 — MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE (February 9, 1990)
  • K883850 — MSI-CAL 16 (November 22, 1988)
  • K883703 — MSI-CAL 7 (November 22, 1988)
  • K883851 — MSI-CAL 8 (November 22, 1988)
  • K880608 — MSI-PC (March 21, 1988)
  • K880270 — MSI-DIFF PLUS (March 1, 1988)

Other clearances for product code CDH

  • K850933 — URIC ACID (June 25, 1985)
  • K821213 — URIC ACID REAGENT SET (July 13, 1982)
  • K813076 — PHOSPHOTUNGSTATE REDUCTION, URIC ACID (November 16, 1981)
  • K810088 — URIC ACID (TPTZ) COLORINMETRIC (January 28, 1981)
  • K800672 — SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (May 28, 1980)
  • K800190 — STANBIO DIRECT URIC ACID TEST SET #0770 (February 13, 1980)
  • K792403 — ELVI URIC ACID-COLORIMETRIC METHOD (December 7, 1979)
  • K792412 — ELVI URIC ACID (December 7, 1979)
  • K790019 — SERUM, URIC ACID DETERMINATION (February 26, 1979)
  • K772082 — ENZAC URIC ACID 100-TEST KIT (November 28, 1977)

FDA data resources