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FDA 510(k)

SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)

K-Number: K860815 · 1986-07-11

ApplicantDiagnostic Products Corp.
Decision Date1986-07-11
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K860815. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)?

SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K860815.

When did SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) receive FDA 510(k) clearance?

SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) received FDA 510(k) clearance on 1986-07-11, under 510(k) number K860815.

Who is the listed applicant for SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)?

The FDA product code for SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) is CDD.

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Related Devices (Code: CDD)

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.

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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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