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FDA 510(k)

DELFIA HLH SPEC KIT

K-Number: K883814 · 1989-03-08

ApplicantPharmacia, Inc.
Decision Date1989-03-08
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA HLH SPEC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1989-03-08 under 510(k) number K883814. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELFIA HLH SPEC KIT?

DELFIA HLH SPEC KIT is a medical device that received FDA 510(k) clearance on 1989-03-08. The listed applicant is Pharmacia, Inc.. The 510(k) number is K883814.

When did DELFIA HLH SPEC KIT receive FDA 510(k) clearance?

DELFIA HLH SPEC KIT received FDA 510(k) clearance on 1989-03-08, under 510(k) number K883814.

Who is the listed applicant for DELFIA HLH SPEC KIT?

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

What is the FDA product code for DELFIA HLH SPEC KIT?

The FDA product code for DELFIA HLH SPEC KIT is CEP.

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Other records listing Pharmacia, 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.

K974350ALLERGAN IMMUNO CAP M4, M8, K70K972364UNICAP PHADIATOPK972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHK962274UNICAP 100

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Related Devices (Code: CEP)

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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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