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FDA 510(k)

SAS QUANT HCG URINE

K-Number: K944891 · 1994-11-17

ApplicantSa Scientific, Inc.
Decision Date1994-11-17
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SAS QUANT HCG URINE is the device name listed in this FDA 510(k) record. The listed applicant is Sa Scientific, Inc.. It received FDA 510(k) clearance on 1994-11-17 under 510(k) number K944891. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAS QUANT HCG URINE?

SAS QUANT HCG URINE is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K944891.

When did SAS QUANT HCG URINE receive FDA 510(k) clearance?

SAS QUANT HCG URINE received FDA 510(k) clearance on 1994-11-17, under 510(k) number K944891.

Who is the listed applicant for SAS QUANT HCG URINE?

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

What is the FDA product code for SAS QUANT HCG URINE?

The FDA product code for SAS QUANT HCG URINE is JJX.

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Other records listing Sa Scientific, 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.

K100227SAS FLUALERT A&B, SAS INFLUENZA A TESTK080380SAS INFLUENZA A & B TESTK041439SAS INFLUENZA B TESTK041441SAS INFLUENZA A TESTK030628SAS RSV CONTROL KITK022845SAS RSV TEST

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Related Devices (Code: JJX)

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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