Helena Biostrip K
FDA 510(k) K830976 · Helena Laboratories
510(k) numberK830976
Submission
- Device name
- Helena Biostrip K
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- March 29, 1983
- Decision date
- May 4, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIN – Nitroprusside, Ketones (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1435
- Specialty
- Clinical Chemistry
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| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring SystemJIN · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/05/2020SE |
| K182593 | KET-1 Blood Ketone Monitoring SystemJIN · Traditional | Apex BioTechnology Corp. | 12/18/2018SE |
| K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemJIN · Traditional | Taidoc Technology Corporation | 05/04/2018SE |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN · Traditional | I-Sens, Inc. | 04/13/2018SE |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for…JIN · Traditional | ACON Laboratories, Inc. | 07/06/2017SE |
| K060768 | Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsJIN · Special | Abbott Diabetes Care, Inc. | 04/21/2006SE |
| K033114 | KetochecksJIN · Traditional | Neo Diagnostics, Inc. | 04/26/2004SE |
| K003987 | URS-1K (Ketone Tesst)JIN · Traditional | Teco Diagnostics | 04/26/2001SE |
| K953662 | First Choice Ketones Urine Test StripsJIN · Traditional | Polymer Technology Intl. | 06/14/1996SE |
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Questions and answers
When was Helena Biostrip K cleared by the FDA?
Helena Biostrip K (K830976) received a 510(k) decision of Substantially Equivalent on May 4, 1983, 36 days after the submission was received.
What is the product code of K830976?
The FDA product code is JIN – Nitroprusside, Ketones (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1435.