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FDA 510(k)

RAPID ONE STEP BUPRENORPHINE TEST CARD

K-Number: K042988 · 2005-05-12

ApplicantTianjin New Bay Bioresearch Co., Ltd.
Decision Date2005-05-12
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPID ONE STEP BUPRENORPHINE TEST CARD is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin New Bay Bioresearch Co., Ltd.. It received FDA 510(k) clearance on 2005-05-12 under 510(k) number K042988. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID ONE STEP BUPRENORPHINE TEST CARD?

RAPID ONE STEP BUPRENORPHINE TEST CARD is a medical device that received FDA 510(k) clearance on 2005-05-12. The listed applicant is Tianjin New Bay Bioresearch Co., Ltd.. The 510(k) number is K042988.

When did RAPID ONE STEP BUPRENORPHINE TEST CARD receive FDA 510(k) clearance?

RAPID ONE STEP BUPRENORPHINE TEST CARD received FDA 510(k) clearance on 2005-05-12, under 510(k) number K042988.

Who is the listed applicant for RAPID ONE STEP BUPRENORPHINE TEST CARD?

The FDA 510(k) record lists Tianjin New Bay Bioresearch Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID ONE STEP BUPRENORPHINE TEST CARD?

The FDA product code for RAPID ONE STEP BUPRENORPHINE TEST CARD is DJG.

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Other records listing Tianjin New Bay Bioresearch Co., Ltd. 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.

K130275QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TESTK122064FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICEK112449QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TESTK071489HOMECHECK MULTIPLE DRUG CUP TESTK073431FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME TK061617FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST

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Related Devices (Code: DJG)

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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