Alkaline Phosphatase (Alp)/Pnpp
FDA 510(k) K761315 · Princeton Biomedix
510(k) numberK761315
Submission
- Device name
- Alkaline Phosphatase (Alp)/Pnpp
- Applicant
- Princeton Biomedix
Mchenry, IL, US - Received
- December 23, 1976
- Decision date
- February 24, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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| K171080 | ALP IFCC Gen.2CJE · Special | Roche Diagnostics Operations (Rdo) | 05/10/2017SE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | Randox Laboratories Limited | 04/21/2017SE |
| K131351 | Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentCJE · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 08/15/2013SE |
| K130141 | S Test Reagent Cartridge Alp (Alkaline Phosphatase)CJE · Traditional | Hitachi Chemical Diagnostics, Inc. | 03/22/2013SE |
| K113436 | Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L ReagentCJE · Traditional | Alfa Wassermann | 07/12/2012SE |
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| K925183 | Biosign(Tm) Mono-Infect Mono Hetero Antibody TestKTN · Traditional | 02/23/1993SE |
| K926308 | Lifesign HCG - One Step Home Pregnancy TestLCX · Traditional | 01/26/1993SE |
| K901011 | Biosign Hcg-One Step Pregnancy TestJHI · Traditional | 05/04/1990SE |
| K894750 | Biostix I. HCG - One Step Pregnancy TestJHI · Traditional | 10/18/1989SE |
| K894705 | Biospot Hcg-Rapid Pregnancy TestJHI · Traditional | 10/18/1989SE |
| K892654 | Biostix (Tm)Hcg--Simple Pregnancy TestDHA · Traditional | 06/19/1989SE |
| K760346 | Assay for Gamma GlutamyltransferaseJPZ · Traditional | 10/27/1976SE |
Questions and answers
When was Alkaline Phosphatase (Alp)/Pnpp cleared by the FDA?
Alkaline Phosphatase (Alp)/Pnpp (K761315) received a 510(k) decision of Substantially Equivalent on February 24, 1977, 63 days after the submission was received.
What is the product code of K761315?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.