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FDA 510(k)

PHADEBAS IGG RAST TEST

K-Number: K810694 · 1981-07-23

ApplicantPharmacia, Inc.
Decision Date1981-07-23
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PHADEBAS IGG RAST TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1981-07-23 under 510(k) number K810694. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHADEBAS IGG RAST TEST?

PHADEBAS IGG RAST TEST is a medical device that received FDA 510(k) clearance on 1981-07-23. The listed applicant is Pharmacia, Inc.. The 510(k) number is K810694.

When did PHADEBAS IGG RAST TEST receive FDA 510(k) clearance?

PHADEBAS IGG RAST TEST received FDA 510(k) clearance on 1981-07-23, under 510(k) number K810694.

Who is the listed applicant for PHADEBAS IGG RAST TEST?

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 PHADEBAS IGG RAST TEST?

The FDA product code for PHADEBAS IGG RAST TEST is DEW.

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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: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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