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FDA 510(k)

RADIAL IMMUNO-TEST FOR HUMAN FACTOR B

K-Number: K831959 · 1983-07-19

ApplicantKent Laboratories, Inc.
Decision Date1983-07-19
Product CodeJZH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RADIAL IMMUNO-TEST FOR HUMAN FACTOR B 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 1983-07-19 under 510(k) number K831959. The device is classified under product code JZH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIAL IMMUNO-TEST FOR HUMAN FACTOR B?

RADIAL IMMUNO-TEST FOR HUMAN FACTOR B is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K831959.

When did RADIAL IMMUNO-TEST FOR HUMAN FACTOR B receive FDA 510(k) clearance?

RADIAL IMMUNO-TEST FOR HUMAN FACTOR B received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831959.

Who is the listed applicant for RADIAL IMMUNO-TEST FOR HUMAN FACTOR B?

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 RADIAL IMMUNO-TEST FOR HUMAN FACTOR B?

The FDA product code for RADIAL IMMUNO-TEST FOR HUMAN FACTOR B is JZH.

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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: JZH)

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.

K964843IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENTBeckman Instruments, Inc.K882623PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEMTechnicon Instruments Corp.K811740KALLESTAD'S ENDOPLATE FACTOR B TESTKallestad Laboratories, Inc.K781016C3PA (GBG) PROPERDIN FACTOR BIcl ScientificK772084LAS-R HUMAN C3 PROACTIVATOR TESTHyland Therapeutic Div., Travenol Laboratories

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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