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FDA 510(k)

QUAD FERM +

K-Number: K853544 · 1985-09-05

ApplicantAnalytical Products, Inc.
Decision Date1985-09-05
Product CodeJSX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUAD FERM + is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Products, Inc.. It received FDA 510(k) clearance on 1985-09-05 under 510(k) number K853544. The device is classified under product code JSX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUAD FERM +?

QUAD FERM + is a medical device that received FDA 510(k) clearance on 1985-09-05. The listed applicant is Analytical Products, Inc.. The 510(k) number is K853544.

When did QUAD FERM + receive FDA 510(k) clearance?

QUAD FERM + received FDA 510(k) clearance on 1985-09-05, under 510(k) number K853544.

Who is the listed applicant for QUAD FERM +?

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

What is the FDA product code for QUAD FERM +?

The FDA product code for QUAD FERM + is JSX.

Other records listing Analytical Products, Inc. as applicant

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Related Devices (Code: JSX)

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.

K960759GONOPOX TEST KITMedtex Laboratories, Inc.K923566NIZYME TEST KITRemel Co.K913456VISI-NEISSERIAKev Connecticut Diagnostics, Inc.K880511XACT NEISSERIAAustin Biological LaboratoriesK881501MODIFIED IDS RAPID NH SYSTEMInnovative Diagnostic Systems, Inc.K870117NEISSERIA/BRANHAMELLA DIFFERENTIAL TESTPro-Lab, 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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