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FDA 510(k)

ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU

K-Number: K781023 · 1978-08-14

ApplicantIcl Scientific
Decision Date1978-08-14
Product CodeDEX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K781023. The device is classified under product code DEX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU?

ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Icl Scientific. The 510(k) number is K781023.

When did ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU receive FDA 510(k) clearance?

ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781023.

Who is the listed applicant for ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU?

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

What is the FDA product code for ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU?

The FDA product code for ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU is DEX.

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Other records listing Icl Scientific 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.

K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLK843565KOVA TROL I,II, III HUMAN URINE-DRIEDK833761THERAPEUTIC DRUG CONTROLK832823ENZYMUNE-TEST TSHK831383EVENT-TEST SLIDEK823199ENZYME-TEST DIGOXIN

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Related Devices (Code: DEX)

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.

K823765ANTI SERA TO HUMAN OROSCOMUCOIDKent Laboratories, Inc.K801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICJ.T. Baker Chemical Co.K791341HUMAN ALPHA, ACID GLYCOPROTEINBeckman Instruments, Inc.K760143SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMANOxford Laboratories, 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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