Total Galactose
FDA 510(k) K894011 · Alpkem Corp.
510(k) numberK894011
Submission
- Device name
- Total Galactose
- Applicant
- Alpkem Corp.
Clackamas, OR, US - Received
- June 6, 1989
- Decision date
- January 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQP – Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1315
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102643 | Spotcheck Neonatal Galt Microplate Reagent KitKQP · Traditional | Astoria-Pacific, Inc. | 07/15/2011SE |
| K101392 | Neopac Software, 3007 Digital Photometer/Fluorometer Model Na, 307 and 350DKQP · Traditional | Astoria-Pacific, Inc. | 02/04/2011SE |
| K100101 | GSP Neonatalgalt Kit, Model 3303-001UKQP · Traditional | Perkinelmer, Inc. | 06/11/2010SE |
| K993536 | Bio-Rad Coda Neonatal Galt AssayKQP · Special | Bio-Rad | 11/04/1999SE |
| K990827 | Microplate Neonatal Galt AssayKQP · Special | Bio-Rad | 04/09/1999SE |
| K970277 | Uridyltransferase Kit, 50 Hour (80-4000-13K)KQP · Traditional | Astoria-Pacific, Inc. | 12/11/1997SE |
More from Astoria-Pacific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K891070 | Phenylalanine (Ninhydrin Reaction)JNB · Traditional | 10/27/1989SE |
| K890334 | Total Cholesterol ReagentCHH · Traditional | 05/03/1989SE |
| K890337 | Triglycerides - Gpo ReagentCDT · Traditional | 03/09/1989SE |
| K890336 | Glucose (God) ReagentCGA · Traditional | 02/27/1989SE |
| K890335 | Sodium Hydroxide Solution, Creatinine Reag./Dilu.CGE · Traditional | 02/17/1989SE |
| K890333 | Albumin ReagentEIX · Traditional | 02/17/1989SE |
| K890332 | RFA/2 Rapid Flow Analyzer W/ComputerJJC · Traditional | 02/17/1989SE |
| K883020 | RFA-300 Rapid Flow Analyzer W/ComputerJJF · Traditional | 09/02/1988SE |
| K860367 | Magnesium (Substrate, Enzyme, Reagent)JGF · Traditional | 04/11/1986SE |
| K852005 | MG ReagentJGJ · Traditional | 06/25/1985SE |
Questions and answers
When was Total Galactose cleared by the FDA?
Total Galactose (K894011) received a 510(k) decision of Substantially Equivalent on January 11, 1990, 219 days after the submission was received.
What is the product code of K894011?
The FDA product code is KQP – Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase, a Class II (moderate risk) device regulated under 21 CFR 862.1315.