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FDA 510(k)

6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497

K-Number: K984384 · 1998-12-23

ApplicantThermo Bioanalysis Corp.
Decision Date1998-12-23
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Bioanalysis Corp.. It received FDA 510(k) clearance on 1998-12-23 under 510(k) number K984384. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497?

6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 is a medical device that received FDA 510(k) clearance on 1998-12-23. The listed applicant is Thermo Bioanalysis Corp.. The 510(k) number is K984384.

When did 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 receive FDA 510(k) clearance?

6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 received FDA 510(k) clearance on 1998-12-23, under 510(k) number K984384.

Who is the listed applicant for 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497?

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

What is the FDA product code for 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497?

The FDA product code for 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 is CHL.

Related Clinical Trials

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Other records listing Thermo Bioanalysis 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.

K981795CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO

Related Devices (Code: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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