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510(k) K830223

FECAL OCCULT SLIDE TEST KIT by Cambridge Chemical Products, Inc. — Product Code KHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1983
Date Received
January 24, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Occult Blood
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

Other clearances by Cambridge Chemical Products, Inc.

  • K860793 — CAMCO STAIN PAK (March 18, 1986)
  • K781347 — CAMCO QUIK STAIN II (August 21, 1978)
  • K770153 — CAMCO R PAK-GUAIAC (February 8, 1977)

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  • K143325 — OC-Light S FIT (August 20, 2015)
  • K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)
  • K113506 — IND ONE STEP OCCULT BLOOD (FOB) TEST (December 19, 2012)
  • K110309 — FOB ONE STEP RAPID TEST (September 14, 2011)
  • K102664 — HEMA SCREEN ER (January 28, 2011)