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FDA 510(k)

MODIFIED SALTEX REAGENT STRIPS

K-Number: K870214 · 1987-06-29

ApplicantMiles Laboratories, Inc.
Decision Date1987-06-29
Product CodeCHK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED SALTEX REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1987-06-29 under 510(k) number K870214. The device is classified under product code CHK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SALTEX REAGENT STRIPS?

MODIFIED SALTEX REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1987-06-29. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K870214.

When did MODIFIED SALTEX REAGENT STRIPS receive FDA 510(k) clearance?

MODIFIED SALTEX REAGENT STRIPS received FDA 510(k) clearance on 1987-06-29, under 510(k) number K870214.

Who is the listed applicant for MODIFIED SALTEX REAGENT STRIPS?

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

What is the FDA product code for MODIFIED SALTEX REAGENT STRIPS?

The FDA product code for MODIFIED SALTEX REAGENT STRIPS is CHK.

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Other records listing Miles Laboratories, 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.

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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