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FDA 510(k)

ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K090057 · 2009-04-08

ApplicantAcon Laboratories Co.
Decision Date2009-04-08
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acon Laboratories Co.. It received FDA 510(k) clearance on 2009-04-08 under 510(k) number K090057. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM?

ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-08. The listed applicant is Acon Laboratories Co.. The 510(k) number is K090057.

When did ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2009-04-08, under 510(k) number K090057.

Who is the listed applicant for ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM is NBW. This falls under the OB/GYN category.

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Other records listing Acon Laboratories 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.

K061559ACON URINALYSIS REAGENT STRIPSK023766ACON STREP A TWIST TEST DEVICEK020313ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICEK010582ACON STREP A RAPID TEST STRIPK980736ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST

Related Devices (Code: NBW)

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.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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