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510(k) K991010

ACP by Abbott Diagnostics Mfg., Inc. — Product Code CKB

K991010 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics Mfg., Inc. for the device "ACP". The FDA issued a decision of Substantially Equivalent on May 19, 1999. The device falls under product code CKB (Acid Phosphatase, Naphthyl Phosphate), a Class II device regulated under 21 CFR 862.1020.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1999
Date Received
March 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Naphthyl Phosphate
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type

Other clearances for product code CKB

  • K053612 — DRI-STAT ACID PHOSPHATASE REAGENT (April 26, 2006)
  • K023840 — ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (January 7, 2003)
  • K981743 — OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (June 9, 1998)
  • K974695 — COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES W (May 21, 1998)
  • K963640 — OLYMPUS ACID PHOSPHATASE REAGENT (February 18, 1997)
  • K943366 — IL TEST ACID PHOSPHATASE (January 29, 1996)
  • K902543 — ACID PHOSPHOTASE REAGENT TEST AND KIT (September 7, 1990)
  • K902495 — ACID PHOSPHATASE REAGENT SET (July 16, 1990)
  • K892393 — ACID PHOSPHATASE REAGENT (July 20, 1989)
  • K884747 — TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) (January 30, 1989)

FDA data resources