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FDA 510(k)

QCLYTE PROTEIN-BASED ISE CONTROL

K-Number: K895582 · 1989-10-04

ApplicantBaxter Healthcare Corp
Decision Date1989-10-04
Product CodeJJR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QCLYTE PROTEIN-BASED ISE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-10-04 under 510(k) number K895582. The device is classified under product code JJR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QCLYTE PROTEIN-BASED ISE CONTROL?

QCLYTE PROTEIN-BASED ISE CONTROL is a medical device that received FDA 510(k) clearance on 1989-10-04. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K895582.

When did QCLYTE PROTEIN-BASED ISE CONTROL receive FDA 510(k) clearance?

QCLYTE PROTEIN-BASED ISE CONTROL received FDA 510(k) clearance on 1989-10-04, under 510(k) number K895582.

Who is the listed applicant for QCLYTE PROTEIN-BASED ISE CONTROL?

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

What is the FDA product code for QCLYTE PROTEIN-BASED ISE CONTROL?

The FDA product code for QCLYTE PROTEIN-BASED ISE CONTROL is JJR.

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Related Devices (Code: JJR)

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.

K990971EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816Medica Corp.K960592ELECTROLYTE STANDARDSPhoenix Diagnostics, Inc.K955630RNA MEDICAL HEMAT CONTROLBionostics, Inc.K951435AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIALAalto Scientific, Ltd.K943925SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTINGQuantimetrix Corp.K934641I-STAT CONTROL LEVELS 1,2,3I-Stat Corp.

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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