Helena Biostrip P
FDA 510(k) K830977 · Helena Laboratories
510(k) numberK830977
Submission
- Device name
- Helena Biostrip P
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- March 29, 1983
- Decision date
- April 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1645
- Specialty
- Clinical Chemistry
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| K022538 | Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special | Diagnostic Chemicals, Ltd. (Usa) | 08/23/2002SE |
| K001810 | Urisite Urine Collection Kit for Microalbumin/Creatinine TestingJIR · Traditional | Flexsite Diagnostics, Inc. | 08/14/2000SE |
| K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15JIR · Traditional | Diagnostic Chemicals , Ltd. | 02/01/2000SE |
| K992257 | New Multiples Reagent StripsJIR · Traditional | Bayer Corp. | 11/24/1999SE |
| K991315 | Microalbustix Reagent Strips (OTC)JIR · Traditional | Bayer Corp. | 11/12/1999SE |
| K983774 | UalbJIR · Traditional | Abbott Laboratories | 01/28/1999SE |
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Questions and answers
When was Helena Biostrip P cleared by the FDA?
Helena Biostrip P (K830977) received a 510(k) decision of Substantially Equivalent on April 28, 1983, 30 days after the submission was received.
What is the product code of K830977?
The FDA product code is JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.