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FDA 510(k)

ANTI SERA TO HUMAN OROSCOMUCOID

K-Number: K823765 · 1982-12-30

ApplicantKent Laboratories, Inc.
Decision Date1982-12-30
Product CodeDEX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI SERA TO HUMAN OROSCOMUCOID is the device name listed in this FDA 510(k) record. The listed applicant is Kent Laboratories, Inc.. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K823765. 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 ANTI SERA TO HUMAN OROSCOMUCOID?

ANTI SERA TO HUMAN OROSCOMUCOID is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K823765.

When did ANTI SERA TO HUMAN OROSCOMUCOID receive FDA 510(k) clearance?

ANTI SERA TO HUMAN OROSCOMUCOID received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823765.

Who is the listed applicant for ANTI SERA TO HUMAN OROSCOMUCOID?

The FDA 510(k) record lists Kent Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTI SERA TO HUMAN OROSCOMUCOID?

The FDA product code for ANTI SERA TO HUMAN OROSCOMUCOID is DEX.

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Other records listing Kent 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.

K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITK951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITK951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITK950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITK85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

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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.

K801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICJ.T. Baker Chemical Co.K791341HUMAN ALPHA, ACID GLYCOPROTEINBeckman Instruments, Inc.K781023ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HUIcl ScientificK760143SERUM, 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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