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510(k) K192730

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV by Biosystems S.A. — Product Code CHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2020
Date Received
September 27, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Titrimetric With Edta And Indicator, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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  • K950897 — BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) (August 24, 1995)
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  • K950899 — LABORATORY SHARPS BARREL (June 29, 1995)

Other clearances for product code CHW

  • K113521 — CALCIUM GEN. 2 (May 8, 2012)
  • K781454 — LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA (September 20, 1978)