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FDA 510(k)

ERMA HB-METER MODEL 303N

K-Number: K854687 · 1986-06-04

ApplicantFuture Impex Corp.
Decision Date1986-06-04
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ERMA HB-METER MODEL 303N is the device name listed in this FDA 510(k) record. The listed applicant is Future Impex Corp.. It received FDA 510(k) clearance on 1986-06-04 under 510(k) number K854687. 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 ERMA HB-METER MODEL 303N?

ERMA HB-METER MODEL 303N is a medical device that received FDA 510(k) clearance on 1986-06-04. The listed applicant is Future Impex Corp.. The 510(k) number is K854687.

When did ERMA HB-METER MODEL 303N receive FDA 510(k) clearance?

ERMA HB-METER MODEL 303N received FDA 510(k) clearance on 1986-06-04, under 510(k) number K854687.

Who is the listed applicant for ERMA HB-METER MODEL 303N?

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

What is the FDA product code for ERMA HB-METER MODEL 303N?

The FDA product code for ERMA HB-METER MODEL 303N is KHG.

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Other records listing Future Impex Corp. 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.

K861487ST-90 SPIRO ANALIZERK854686TE-25 COAGURO METERK854685DIGITAL-9 KEY LEUCOCYTE COUNTERK854677ERMA PC-604 BLOOD CELL COUNTERK854678ERMA PC-602 PC-603 BLOOD CELL COUNTERK854679PHOTIC-100 SPECTROPHOTOMETER

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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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