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FDA 510(k)

BAKER TDM THEOPHYLLINE ASSAY

K-Number: K873596 · 1987-10-20

ApplicantBaker Instructions Corp.
Decision Date1987-10-20
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BAKER TDM THEOPHYLLINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Baker Instructions Corp.. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K873596. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAKER TDM THEOPHYLLINE ASSAY?

BAKER TDM THEOPHYLLINE ASSAY is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Baker Instructions Corp.. The 510(k) number is K873596.

When did BAKER TDM THEOPHYLLINE ASSAY receive FDA 510(k) clearance?

BAKER TDM THEOPHYLLINE ASSAY received FDA 510(k) clearance on 1987-10-20, under 510(k) number K873596.

Who is the listed applicant for BAKER TDM THEOPHYLLINE ASSAY?

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

What is the FDA product code for BAKER TDM THEOPHYLLINE ASSAY?

The FDA product code for BAKER TDM THEOPHYLLINE ASSAY is KLS.

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Other records listing Baker Instructions 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.

K882612SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTERK870603SYSTEM 9000 AUTOMATED CELL COUNTERK854173UCD URINE SPECIMEN COLLECTORK850386SYSTEM 8000 CELL COUNTERK833116SPIRIT CHEMISTRY SYSTEMK832716ENCORE CHEMISTRY ANALYZER

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Related Devices (Code: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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