Helena Biostrip PH
FDA 510(k) K830979 · Helena Laboratories
510(k) numberK830979
Submission
- Device name
- Helena Biostrip PH
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- March 29, 1983
- Decision date
- May 5, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1550
- Specialty
- Clinical Chemistry
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| K962718 | Femexam TestcardCEN · Traditional | Litmus Concepts, Inc. | 02/07/1997SE |
| K840827 | Kyotest 5VCEN · Traditional | Kyoto Diagnostics, Inc. | 05/14/1984SE |
| K830824 | Urine Screening KitCEN · Traditional | Syn-Kit, Inc. | 06/12/1983SE |
| K830091 | Lith a Test TMCEN · Traditional | Lenal Creative Approaches, Inc. | 02/15/1983SE |
| K822241 | FOLATE/B12 Duo-Bead RadioassayCEN · Traditional | Abbott Laboratories | 10/26/1982SE |
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Questions and answers
When was Helena Biostrip PH cleared by the FDA?
Helena Biostrip PH (K830979) received a 510(k) decision of Substantially Equivalent on May 5, 1983, 37 days after the submission was received.
What is the product code of K830979?
The FDA product code is CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative), a Class I (low risk) device regulated under 21 CFR 862.1550.