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510(k) K761304

JTB 700 HEMATOLOGY ANALYZER by J.T. Baker Chemical Co. — Product Code JPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1977
Date Received
December 22, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Red-Cell Indices, Calculated
Device Class
Class II
Regulation Number
864.5300
Review Panel
HE
Submission Type

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  • K801662 — J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. (September 16, 1980)
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  • K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (September 16, 1980)
  • K801795 — BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. (September 16, 1980)
  • K801362 — ALBUMIN NEPHELOMETRIC ASSAY (July 21, 1980)
  • K801433 — HAPTOGLOBIN NEPHELOMETRIC ASSAY (July 8, 1980)

Other clearances for product code JPJ

  • K904675 — QBC SYSTEM MCHC (November 2, 1990)
  • K780946 — ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER (July 27, 1978)