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FDA 510(k)

STAT-SIMPLE PYLORI

K-Number: K980782 · 1998-08-05

ApplicantSaliva Diagnostic Systems, Inc.
Decision Date1998-08-05
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STAT-SIMPLE PYLORI is the device name listed in this FDA 510(k) record. The listed applicant is Saliva Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1998-08-05 under 510(k) number K980782. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT-SIMPLE PYLORI?

STAT-SIMPLE PYLORI is a medical device that received FDA 510(k) clearance on 1998-08-05. The listed applicant is Saliva Diagnostic Systems, Inc.. The 510(k) number is K980782.

When did STAT-SIMPLE PYLORI receive FDA 510(k) clearance?

STAT-SIMPLE PYLORI received FDA 510(k) clearance on 1998-08-05, under 510(k) number K980782.

Who is the listed applicant for STAT-SIMPLE PYLORI?

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

What is the FDA product code for STAT-SIMPLE PYLORI?

The FDA product code for STAT-SIMPLE PYLORI is LYR.

Related Clinical Trials

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.

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Other records listing Saliva Diagnostic Systems, 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.

K942435SALIVA SAMPLER

Related Devices (Code: LYR)

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.

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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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