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FDA 510(k)

CHEMSTRIP CONTROL

K-Number: K781691 · 1978-12-20

ApplicantBoehringer Mannheim Corp.
Decision Date1978-12-20
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMSTRIP CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K781691. 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 CHEMSTRIP CONTROL?

CHEMSTRIP CONTROL is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K781691.

When did CHEMSTRIP CONTROL receive FDA 510(k) clearance?

CHEMSTRIP CONTROL received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781691.

Who is the listed applicant for CHEMSTRIP CONTROL?

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

What is the FDA product code for CHEMSTRIP CONTROL?

The FDA product code for CHEMSTRIP CONTROL is JJW.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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