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FDA 510(k)

KEMBLE 405

K-Number: K842894 · 1984-08-27

ApplicantKemble Instruments, Inc.
Decision Date1984-08-27
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KEMBLE 405 is the device name listed in this FDA 510(k) record. The listed applicant is Kemble Instruments, Inc.. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K842894. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEMBLE 405?

KEMBLE 405 is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Kemble Instruments, Inc.. The 510(k) number is K842894.

When did KEMBLE 405 receive FDA 510(k) clearance?

KEMBLE 405 received FDA 510(k) clearance on 1984-08-27, under 510(k) number K842894.

Who is the listed applicant for KEMBLE 405?

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

What is the FDA product code for KEMBLE 405?

The FDA product code for KEMBLE 405 is JQW.

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Other records listing Kemble Instruments, 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.

K832734KEMTEK 400 RIA GAMMA COUNTERK832760RIA SOFTWAREK832736KEMTEK 104 RIA GAMMA COUNTERK832735KEMTEK 103 RIA GAMMA COUNTERK830751KEMTEK 102K822293IMMU-COUNT 404

View all 9 devices →

Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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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