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FDA 510(k)

MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE

K-Number: K875079 · 1988-04-05

ApplicantMiles Laboratories, Inc.
Decision Date1988-04-05
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE 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 1988-04-05 under 510(k) number K875079. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE?

MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K875079.

When did MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE receive FDA 510(k) clearance?

MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE received FDA 510(k) clearance on 1988-04-05, under 510(k) number K875079.

Who is the listed applicant for MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE?

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 SERALYZER ALT/SGPT REAG. STRIPS & MODULE?

The FDA product code for MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE is CKA.

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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 TABLETSK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)K872634CUTTER PUREFLO PLUS IV FILTER

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Related Devices (Code: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, 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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