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FDA 510(k)

KALLESTAD'S ENDOPLATE FACTOR B TEST

K-Number: K811740 · 1981-07-16

ApplicantKallestad Laboratories, Inc.
Decision Date1981-07-16
Product CodeJZH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KALLESTAD'S ENDOPLATE FACTOR B TEST is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1981-07-16 under 510(k) number K811740. 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 KALLESTAD'S ENDOPLATE FACTOR B TEST?

KALLESTAD'S ENDOPLATE FACTOR B TEST is a medical device that received FDA 510(k) clearance on 1981-07-16. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K811740.

When did KALLESTAD'S ENDOPLATE FACTOR B TEST receive FDA 510(k) clearance?

KALLESTAD'S ENDOPLATE FACTOR B TEST received FDA 510(k) clearance on 1981-07-16, under 510(k) number K811740.

Who is the listed applicant for KALLESTAD'S ENDOPLATE FACTOR B TEST?

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

What is the FDA product code for KALLESTAD'S ENDOPLATE FACTOR B TEST?

The FDA product code for KALLESTAD'S ENDOPLATE FACTOR B TEST is JZH.

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Other records listing Kallestad Laboratories, Inc. as applicant

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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.K831959RADIAL IMMUNO-TEST FOR HUMAN FACTOR BKent 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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