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510(k) K841052

CHOLESTEROL REAGENT SET by Medical Specialties, Inc. — Product Code CHD

K841052 is an FDA 510(k) premarket notification submitted by Medical Specialties, Inc. for the device "CHOLESTEROL REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 1, 1984. The device falls under product code CHD (Acid, Ferric Ion-Sulfuric, Cholesterol), a Class I device regulated under 21 CFR 862.1175. 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, Ferric Ion-Sulfuric, Cholesterol
Device Class
Class I
Regulation Number
862.1175
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 CHD

  • K830616 — ACTIVATED URIC ACID (April 5, 1983)
  • K821195 — CHOLESTEROL REAGENT SET (July 13, 1982)

FDA data resources