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FDA 510(k)

URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE

K-Number: K860143 · 1986-02-10

ApplicantReagent Laboratory, Inc.
Decision Date1986-02-10
Product CodeJJP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Reagent Laboratory, Inc.. It received FDA 510(k) clearance on 1986-02-10 under 510(k) number K860143. The device is classified under product code JJP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE?

URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-02-10. The listed applicant is Reagent Laboratory, Inc.. The 510(k) number is K860143.

When did URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE receive FDA 510(k) clearance?

URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE received FDA 510(k) clearance on 1986-02-10, under 510(k) number K860143.

Who is the listed applicant for URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE?

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

What is the FDA product code for URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE?

The FDA product code for URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE is JJP.

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Other records listing Reagent Laboratory, 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.

K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/LK863503HEMOLYSEK863550POTASSIUM HYDROXIDE 10% W/VK842982FORMALIN BUFFEREDK843050GRAM STAINK842785STAIN, METHYLENE BLUE-EOSIN

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Related Devices (Code: JJP)

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.

K900280CENTRIPREP 100Amicon, Inc.K863438NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZERNova Biomedical Corp.

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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