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FDA 510(k)

KIT, METHADONE (TOXI-PAK IMMUNO HI)

K-Number: K760075 · 1976-07-20

ApplicantJ.T. Baker Chemical Co.
Decision Date1976-07-20
Product CodeDIW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

KIT, METHADONE (TOXI-PAK IMMUNO HI) is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1976-07-20 under 510(k) number K760075. The device is classified under product code DIW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIT, METHADONE (TOXI-PAK IMMUNO HI)?

KIT, METHADONE (TOXI-PAK IMMUNO HI) is a medical device that received FDA 510(k) clearance on 1976-07-20. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K760075.

When did KIT, METHADONE (TOXI-PAK IMMUNO HI) receive FDA 510(k) clearance?

KIT, METHADONE (TOXI-PAK IMMUNO HI) received FDA 510(k) clearance on 1976-07-20, under 510(k) number K760075.

Who is the listed applicant for KIT, METHADONE (TOXI-PAK IMMUNO HI)?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIT, METHADONE (TOXI-PAK IMMUNO HI)?

The FDA product code for KIT, METHADONE (TOXI-PAK IMMUNO HI) is DIW.

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Other records listing J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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Related Devices (Code: DIW)

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.

K950182URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGEE.I. Dupont DE Nemours & Co., Inc.K930845ROCHE ABUSCREEN ONTRAK FOR METHADONERoche Diagnostic Systems, Inc.K801509HI-M-TEST FOR METHADONE TEST #2Technam, 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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