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FDA 510(k)

TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)

K-Number: K884747 · 1989-01-30

ApplicantTechnicon Instruments Corp.
Decision Date1989-01-30
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1989-01-30 under 510(k) number K884747. The device is classified under product code CKB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)?

TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K884747.

When did TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) receive FDA 510(k) clearance?

TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) received FDA 510(k) clearance on 1989-01-30, under 510(k) number K884747.

Who is the listed applicant for TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)?

The FDA 510(k) record lists Technicon Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)?

The FDA product code for TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) is CKB.

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Other records listing Technicon Instruments Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: CKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K053612DRI-STAT ACID PHOSPHATASE REAGENTBeckman Coulter, Inc.K023840ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650Bayer Diagnostics Corp.K991010ACPAbbott Diagnostics Mfg., Inc.K981743OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.K974695COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)Roche Diagnostic Systems, Inc.K963640OLYMPUS ACID PHOSPHATASE REAGENTOlympus America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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