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FDA 510(k)

AMES SERA-PAK HEMOGLOBIN REAGENT

K-Number: K803248 · 1981-01-26

ApplicantMiles Laboratories, Inc.
Decision Date1981-01-26
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AMES SERA-PAK HEMOGLOBIN REAGENT 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 1981-01-26 under 510(k) number K803248. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES SERA-PAK HEMOGLOBIN REAGENT?

AMES SERA-PAK HEMOGLOBIN REAGENT is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K803248.

When did AMES SERA-PAK HEMOGLOBIN REAGENT receive FDA 510(k) clearance?

AMES SERA-PAK HEMOGLOBIN REAGENT received FDA 510(k) clearance on 1981-01-26, under 510(k) number K803248.

Who is the listed applicant for AMES SERA-PAK HEMOGLOBIN REAGENT?

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 AMES SERA-PAK HEMOGLOBIN REAGENT?

The FDA product code for AMES SERA-PAK HEMOGLOBIN REAGENT is KHG.

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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: KHG)

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.

K221508AnemoCheck HomeSanguina, Inc.K163215AnemoCheckSanguina, LLCK042379ANEMIAPRO SELF-SCREENERBiosafe Laboratories, Inc.K020138STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090Gds TechnologyK001462CARESIDE HEMOGLOBINCareside, Inc.K994073HEMOSITE TEST SYSTEMGds Technology, LLC

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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