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FDA 510(k)

ALTERNATE PROCEDURE, PHARMACIA IGE EIA

K-Number: K882616 · 1988-08-04

ApplicantPharmacia, Inc.
Decision Date1988-08-04
Product CodeJHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALTERNATE PROCEDURE, PHARMACIA IGE EIA is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K882616. The device is classified under product code JHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALTERNATE PROCEDURE, PHARMACIA IGE EIA?

ALTERNATE PROCEDURE, PHARMACIA IGE EIA is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Pharmacia, Inc.. The 510(k) number is K882616.

When did ALTERNATE PROCEDURE, PHARMACIA IGE EIA receive FDA 510(k) clearance?

ALTERNATE PROCEDURE, PHARMACIA IGE EIA received FDA 510(k) clearance on 1988-08-04, under 510(k) number K882616.

Who is the listed applicant for ALTERNATE PROCEDURE, PHARMACIA IGE EIA?

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 ALTERNATE PROCEDURE, PHARMACIA IGE EIA?

The FDA product code for ALTERNATE PROCEDURE, PHARMACIA IGE EIA is JHR.

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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: JHR)

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.

K061970ELECSYS IGE II IMMUNOASSAYRoche DiagnosticsK984326ELECYS IGE ASSAYBoehringer Mannheim Corp.K960067IMMILITE TOTAL IGEDiagnostic Products Corp.K931703IMMULITE TOTAL IGEDiagnostic Products Corp.K903000TURBO-RAST SPECIFIC IGE ASSAYVentrex Laboratories, Inc.K901859COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2Diagnostic Products Corp.

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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