BTC Urine LH Assay
FDA 510(k) K833710 · Btc Diagnostics, Inc.
510(k) numberK833710
Submission
- Device name
- BTC Urine LH Assay
- Applicant
- Btc Diagnostics, Inc.
Mchenry, IL, US - Received
- October 20, 1983
- Decision date
- January 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CED – 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1520
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894288 | Phosphorus Test Item Number 65416CED · Traditional | Em Diagnostic Systems, Inc. | 08/31/1989SE |
| K840151 | Ektachem Clinical Chem. SlidesCED · Traditional | Eastman Kodak Company | 03/22/1984SE |
| K820832 | Phosphorus IlCED · Traditional | American Monitor Corp. | 04/15/1982SE |
| K812670 | Sandare Fast 340 Phosphorus ProcedureCED · Traditional | Sandare Chemical Co., Inc. | 10/02/1981SE |
| K811864 | Sigma Procedure 265-UVCED · Traditional | Sigma Chemical Co. | 07/31/1981SE |
| K811222 | Inorganic Phosphorus ReagentsCED · Traditional | Connecticut Diagnostics, Ltd. | 05/21/1981SE |
| K802420 | Centrifichem Inorganic PhosphorusCED · Traditional | Union Carbide Corp. | 10/31/1980SE |
| K790662 | Centrifichem Inorganic PhosphorusCED · Traditional | Union Carbide Corp. | 05/15/1979SE |
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Questions and answers
When was BTC Urine LH Assay cleared by the FDA?
BTC Urine LH Assay (K833710) received a 510(k) decision of Substantially Equivalent on January 30, 1984, 102 days after the submission was received.
What is the product code of K833710?
The FDA product code is CED – 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase, a Class I (low risk) device regulated under 21 CFR 862.1520.