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FDA 510(k)

V-TREND QC TDM CONTROL SERUM 1,2,3.

K-Number: K862817 · 1986-08-19

ApplicantTexas Immunology, Inc.
Decision Date1986-08-19
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

V-TREND QC TDM CONTROL SERUM 1,2,3. is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862817. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-TREND QC TDM CONTROL SERUM 1,2,3.?

V-TREND QC TDM CONTROL SERUM 1,2,3. is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K862817.

When did V-TREND QC TDM CONTROL SERUM 1,2,3. receive FDA 510(k) clearance?

V-TREND QC TDM CONTROL SERUM 1,2,3. received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862817.

Who is the listed applicant for V-TREND QC TDM CONTROL SERUM 1,2,3.?

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

What is the FDA product code for V-TREND QC TDM CONTROL SERUM 1,2,3.?

The FDA product code for V-TREND QC TDM CONTROL SERUM 1,2,3. is DIF.

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Other records listing Texas Immunology, Inc. as applicant

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K991465DRUG STOPK980153DRUG CHECKK973208FIRST SIGNK972094TARGET CARDIAC TROPONIN I TESTK963680TARGET MYOGLOBIN TESTK912246TARGET MICROALBUMINURIA TEST

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Related Devices (Code: DIF)

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.

K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBiochemical Diagnostics, Inc.K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.K132174MULTICHEM WBTTechno-Path Manufacturing , Ltd.K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad LaboratoriesK120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, 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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