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510(k) K883683

HEMOGLOBIN by Tech-Co, Inc. — Product Code GJZ

K883683 is an FDA 510(k) premarket notification submitted by Tech-Co, Inc. for the device "HEMOGLOBIN". The FDA issued a decision of Substantially Equivalent on October 6, 1988. The device falls under product code GJZ (Cyanomethemoglobin Reagent And Standard Solution), a Class II device regulated under 21 CFR 864.7500. Tech-Co, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1988
Date Received
August 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cyanomethemoglobin Reagent And Standard Solution
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

Other clearances by Tech-Co, Inc.

  • K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (June 28, 1996)
  • K923376 — VISUAL HCG PREGNANCY TEST (October 1, 1992)
  • K920766 — T4 EIA BEAD ASSAY (April 17, 1992)
  • K920716 — DIRECT PREGNANCY TEST (March 24, 1992)
  • K902574 — POTASSIUM REAGENT SET (July 10, 1990)
  • K901561 — IRON/TOTAL IRON BINDING CAPACITY (May 17, 1990)
  • K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (October 13, 1988)
  • K883386 — CHLORIDE (October 6, 1988)
  • K881173 — ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) (June 7, 1988)
  • K881172 — BILIRUBIN (DIRECT) (June 7, 1988)

Other clearances for product code GJZ

  • K881242 — CELL-DYN RAPID-LYSE AND HEMOGLOBLIN (April 21, 1988)

FDA data resources