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FDA 510(k)

PHADEZYM B2 MICRO TEST 100

K-Number: K830280 · 1983-03-25

ApplicantPharmacia, Inc.
Decision Date1983-03-25
Product Code
DecisionSubstantially Equivalent

Device Summary

PHADEZYM B2 MICRO TEST 100 is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1983-03-25 under 510(k) number K830280. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHADEZYM B2 MICRO TEST 100?

PHADEZYM B2 MICRO TEST 100 is a medical device that received FDA 510(k) clearance on 1983-03-25. The listed applicant is Pharmacia, Inc.. The 510(k) number is K830280.

When did PHADEZYM B2 MICRO TEST 100 receive FDA 510(k) clearance?

PHADEZYM B2 MICRO TEST 100 received FDA 510(k) clearance on 1983-03-25, under 510(k) number K830280.

Who is the listed applicant for PHADEZYM B2 MICRO TEST 100?

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

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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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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