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FDA 510(k)

ISOTONIC BLOOD CELL DILUENT J & S

K-Number: K833443 · 1983-11-03

ApplicantJasins & Sayles Associates, Inc.
Decision Date1983-11-03
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ISOTONIC BLOOD CELL DILUENT J & S is the device name listed in this FDA 510(k) record. The listed applicant is Jasins & Sayles Associates, Inc.. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K833443. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOTONIC BLOOD CELL DILUENT J & S?

ISOTONIC BLOOD CELL DILUENT J & S is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Jasins & Sayles Associates, Inc.. The 510(k) number is K833443.

When did ISOTONIC BLOOD CELL DILUENT J & S receive FDA 510(k) clearance?

ISOTONIC BLOOD CELL DILUENT J & S received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833443.

Who is the listed applicant for ISOTONIC BLOOD CELL DILUENT J & S?

The FDA 510(k) record lists Jasins & Sayles Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOTONIC BLOOD CELL DILUENT J & S?

The FDA product code for ISOTONIC BLOOD CELL DILUENT J & S is GIF.

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Other records listing Jasins & Sayles Associates, 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.

K833444LYSING & HEMOGLOBIN S-REAGENT J & S

Related Devices (Code: GIF)

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.

K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K883990KVM ISOTONIC DILUENTKvm Technologies, Inc.K882490HYCEL QUICK-LYSING HEMOGLOBIN REAGENTR&D Systems, Inc.K882267SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, Inc.K881130CELL-DYN ISOTONIC DILUENTAbbott DiagnosticsK873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott Diagnostics

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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