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FDA 510(k)

SODIUM CHLORIDE SOLUTION BLOOD CELL

K-Number: K841183 · 1984-05-21

ApplicantReagent Laboratory, Inc.
Decision Date1984-05-21
Product CodeFNW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SODIUM CHLORIDE SOLUTION BLOOD CELL is the device name listed in this FDA 510(k) record. The listed applicant is Reagent Laboratory, Inc.. It received FDA 510(k) clearance on 1984-05-21 under 510(k) number K841183. The device is classified under product code FNW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODIUM CHLORIDE SOLUTION BLOOD CELL?

SODIUM CHLORIDE SOLUTION BLOOD CELL is a medical device that received FDA 510(k) clearance on 1984-05-21. The listed applicant is Reagent Laboratory, Inc.. The 510(k) number is K841183.

When did SODIUM CHLORIDE SOLUTION BLOOD CELL receive FDA 510(k) clearance?

SODIUM CHLORIDE SOLUTION BLOOD CELL received FDA 510(k) clearance on 1984-05-21, under 510(k) number K841183.

Who is the listed applicant for SODIUM CHLORIDE SOLUTION BLOOD CELL?

The FDA 510(k) record lists Reagent Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SODIUM CHLORIDE SOLUTION BLOOD CELL?

The FDA product code for SODIUM CHLORIDE SOLUTION BLOOD CELL is FNW.

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Other records listing Reagent Laboratory, Inc. 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.

K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/LK863503HEMOLYSEK863550POTASSIUM HYDROXIDE 10% W/VK860143URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODEK842982FORMALIN BUFFEREDK842785STAIN, METHYLENE BLUE-EOSIN

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Related Devices (Code: FNW)

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.

K831117MICROMAT W/VARIOUS MODELSPmt, 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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