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FDA 510(k)

SERALYZER LDH REAGENT STRIPS, CALIBR

K-Number: K803019 · 1980-12-22

ApplicantMiles Laboratories, Inc.
Decision Date1980-12-22
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERALYZER LDH REAGENT STRIPS, CALIBR 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 1980-12-22 under 510(k) number K803019. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERALYZER LDH REAGENT STRIPS, CALIBR?

SERALYZER LDH REAGENT STRIPS, CALIBR is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K803019.

When did SERALYZER LDH REAGENT STRIPS, CALIBR receive FDA 510(k) clearance?

SERALYZER LDH REAGENT STRIPS, CALIBR received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803019.

Who is the listed applicant for SERALYZER LDH REAGENT STRIPS, CALIBR?

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 SERALYZER LDH REAGENT STRIPS, CALIBR?

The FDA product code for SERALYZER LDH REAGENT STRIPS, CALIBR is CFJ.

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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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Related Devices (Code: CFJ)

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.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

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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