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FDA 510(k)

SERACON CT REFERENCE

K-Number: K863648 · 1986-10-29

ApplicantBhp Diagnostix, Inc.
Decision Date1986-10-29
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERACON CT REFERENCE 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 1986-10-29 under 510(k) number K863648. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERACON CT REFERENCE?

SERACON CT REFERENCE is a medical device that received FDA 510(k) clearance on 1986-10-29. The listed applicant is Bhp Diagnostix, Inc.. The 510(k) number is K863648.

When did SERACON CT REFERENCE receive FDA 510(k) clearance?

SERACON CT REFERENCE received FDA 510(k) clearance on 1986-10-29, under 510(k) number K863648.

Who is the listed applicant for SERACON CT REFERENCE?

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 CT REFERENCE?

The FDA product code for SERACON CT REFERENCE is JJY.

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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 REFERENCEK862594SERACON(TM) CAL (PRODUCT NO. DO35)K844927QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETSK844928QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCEK844027SERACON TM SR IIIK844026SERACON TM SR IV

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Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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