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FDA 510(k)

NEPHELOMETER

K-Number: K780251 · 1978-04-06

ApplicantKallestad Laboratories, Inc.
Decision Date1978-04-06
Product CodeJQX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEPHELOMETER 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 1978-04-06 under 510(k) number K780251. The device is classified under product code JQX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEPHELOMETER?

NEPHELOMETER is a medical device that received FDA 510(k) clearance on 1978-04-06. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K780251.

When did NEPHELOMETER receive FDA 510(k) clearance?

NEPHELOMETER received FDA 510(k) clearance on 1978-04-06, under 510(k) number K780251.

Who is the listed applicant for NEPHELOMETER?

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 NEPHELOMETER?

The FDA product code for NEPHELOMETER is JQX.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: JQX)

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.

K962294IMMAGE IMMUNOCHEMISTRY SYSTEMBeckman Instruments, Inc.K922273ARRAY(R) 360Beckman Instruments, Inc.K885263QMS(TM) - THEOPHYLLINESeradyn, Inc.K851253TDX ANALYZER W/NEPHELOMETRY CAROUSELAbbott LaboratoriesK851234A-JUST TURBIDITY METERAbbott LaboratoriesK801362ALBUMIN NEPHELOMETRIC ASSAYJ.T. Baker Chemical Co.

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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