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FDA 510(k)

MASTERCAP AM 5.0/MASTERCAP RM 5.0

K-Number: K970420 · 1997-06-30

ApplicantPharmacia, Inc.
Decision Date1997-06-30
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MASTERCAP AM 5.0/MASTERCAP RM 5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1997-06-30 under 510(k) number K970420. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTERCAP AM 5.0/MASTERCAP RM 5.0?

MASTERCAP AM 5.0/MASTERCAP RM 5.0 is a medical device that received FDA 510(k) clearance on 1997-06-30. The listed applicant is Pharmacia, Inc.. The 510(k) number is K970420.

When did MASTERCAP AM 5.0/MASTERCAP RM 5.0 receive FDA 510(k) clearance?

MASTERCAP AM 5.0/MASTERCAP RM 5.0 received FDA 510(k) clearance on 1997-06-30, under 510(k) number K970420.

Who is the listed applicant for MASTERCAP AM 5.0/MASTERCAP RM 5.0?

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 MASTERCAP AM 5.0/MASTERCAP RM 5.0?

The FDA product code for MASTERCAP AM 5.0/MASTERCAP RM 5.0 is JQW.

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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 K82K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHK962274UNICAP 100K941993PHARMACIA CAP SYSTEM PHADIATOP FEIA

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Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute DiagnosticsK962859MINI SAMPLE PROCESSORCavro Scientific Instruments, Inc.

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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