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510(k) K872886

CARBON DIOXIDE by Catachem, Inc. — Product Code KMS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1987
Date Received
July 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phenolphthalein Colorimetry, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

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Other clearances for product code KMS

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  • K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (May 30, 1980)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)