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FDA 510(k)

THERACHEM-PLUS, TRI-LEVEL TDC (TM)

K-Number: K861185 · 1986-05-23

ApplicantFisher Scientific Co., LLC
Decision Date1986-05-23
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THERACHEM-PLUS, TRI-LEVEL TDC (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K861185. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERACHEM-PLUS, TRI-LEVEL TDC (TM)?

THERACHEM-PLUS, TRI-LEVEL TDC (TM) is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K861185.

When did THERACHEM-PLUS, TRI-LEVEL TDC (TM) receive FDA 510(k) clearance?

THERACHEM-PLUS, TRI-LEVEL TDC (TM) received FDA 510(k) clearance on 1986-05-23, under 510(k) number K861185.

Who is the listed applicant for THERACHEM-PLUS, TRI-LEVEL TDC (TM)?

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

What is the FDA product code for THERACHEM-PLUS, TRI-LEVEL TDC (TM)?

The FDA product code for THERACHEM-PLUS, TRI-LEVEL TDC (TM) is JJY.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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