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510(k) K841054

DIRECT GLUCOSE REAGENT SET by Medical Specialties, Inc. — Product Code CGE

K841054 is an FDA 510(k) premarket notification submitted by Medical Specialties, Inc. for the device "DIRECT GLUCOSE REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 1, 1984. The device falls under product code CGE (Orthotoluidine, Glucose), a Class II device regulated under 21 CFR 862.1345. 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
Orthotoluidine, Glucose
Device Class
Class II
Regulation Number
862.1345
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 CGE

  • K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (February 17, 1989)
  • K855185 — GLUCOSE REAGENT SET (January 22, 1986)
  • K850930 — GLUCOSE (June 10, 1985)
  • K821198 — DIRECT GLUCOSE REAGENT SET (July 13, 1982)
  • K811883 — KING DIAGNOSTICS GLUCOSE-O TEST (July 23, 1981)
  • K810089 — 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI (January 26, 1981)
  • K790319 — ORTHO-TOLUIDINE REAGENT SET (March 21, 1979)
  • K781308 — GLUCOLOUR (August 31, 1978)
  • K771314 — GLUCOSE REAGENT (O-TOLUIDINE) (August 3, 1977)
  • K771091 — UNIPAK GLUCOSE (July 21, 1977)

FDA data resources