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FDA 510(k)

SERACON - EL DO27

K-Number: K791958 · 1979-10-17

ApplicantBhp Diagnostix, Inc.
Decision Date1979-10-17
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERACON - EL DO27 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 1979-10-17 under 510(k) number K791958. 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 - EL DO27?

SERACON - EL DO27 is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Bhp Diagnostix, Inc.. The 510(k) number is K791958.

When did SERACON - EL DO27 receive FDA 510(k) clearance?

SERACON - EL DO27 received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791958.

Who is the listed applicant for SERACON - EL DO27?

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 - EL DO27?

The FDA product code for SERACON - EL DO27 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 REFERENCEK863648SERACON CT REFERENCEK862594SERACON(TM) CAL (PRODUCT NO. DO35)K844928QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCEK844927QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETSK844026SERACON TM SR IV

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Related Devices (Code: JJY)

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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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