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FDA 510(k)

BIOCHECK POSITIVE URINE CONTROL

K-Number: K831994 · 1983-08-08

ApplicantHelena Laboratories
Decision Date1983-08-08
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOCHECK POSITIVE URINE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1983-08-08 under 510(k) number K831994. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHECK POSITIVE URINE CONTROL?

BIOCHECK POSITIVE URINE CONTROL is a medical device that received FDA 510(k) clearance on 1983-08-08. The listed applicant is Helena Laboratories. The 510(k) number is K831994.

When did BIOCHECK POSITIVE URINE CONTROL receive FDA 510(k) clearance?

BIOCHECK POSITIVE URINE CONTROL received FDA 510(k) clearance on 1983-08-08, under 510(k) number K831994.

Who is the listed applicant for BIOCHECK POSITIVE URINE CONTROL?

The FDA 510(k) record lists Helena Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCHECK POSITIVE URINE CONTROL?

The FDA product code for BIOCHECK POSITIVE URINE CONTROL is JJW.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: JJW)

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.

K170091UA-Cellular CompleteStreckK110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories LimitedK103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa CorporationK072640IRISPEC,CA/CB/CCIris DiagnosticsK070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.

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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