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FDA 510(k)

SERACON CR REFERENCE

K-Number: K904503 · 1990-11-02

ApplicantBhp Diagnostix, Inc.
Decision Date1990-11-02
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERACON CR 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 1990-11-02 under 510(k) number K904503. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERACON CR REFERENCE?

SERACON CR REFERENCE is a medical device that received FDA 510(k) clearance on 1990-11-02. The listed applicant is Bhp Diagnostix, Inc.. The 510(k) number is K904503.

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

SERACON CR REFERENCE received FDA 510(k) clearance on 1990-11-02, under 510(k) number K904503.

Who is the listed applicant for SERACON CR 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 CR REFERENCE?

The FDA product code for SERACON CR REFERENCE is JJX.

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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.

K863648SERACON CT 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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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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