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FDA 510(k)

SERACON(TM) CAL (PRODUCT NO. DO35)

K-Number: K862594 · 1986-08-19

ApplicantBhp Diagnostix, Inc.
Decision Date1986-08-19
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERACON(TM) CAL (PRODUCT NO. DO35) is the device name listed in this FDA 510(k) record. The listed applicant is Bhp Diagnostix, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862594. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERACON(TM) CAL (PRODUCT NO. DO35)?

SERACON(TM) CAL (PRODUCT NO. DO35) is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Bhp Diagnostix, Inc.. The 510(k) number is K862594.

When did SERACON(TM) CAL (PRODUCT NO. DO35) receive FDA 510(k) clearance?

SERACON(TM) CAL (PRODUCT NO. DO35) received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862594.

Who is the listed applicant for SERACON(TM) CAL (PRODUCT NO. DO35)?

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

What is the FDA product code for SERACON(TM) CAL (PRODUCT NO. DO35)?

The FDA product code for SERACON(TM) CAL (PRODUCT NO. DO35) is JIX.

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Other records listing Bhp Diagnostix, 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.

K904503SERACON CR REFERENCEK863648SERACON CT REFERENCEK844927QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETSK844928QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCEK844027SERACON TM SR IIIK844026SERACON TM SR IV

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

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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