Absorbance (Abs) Test Pak
FDA 510(k) K854784 · Diagnostic Systems
510(k) numberK854784
Submission
- Device name
- Absorbance (Abs) Test Pak
- Applicant
- Diagnostic Systems
Gibbstown, NJ, US - Received
- November 29, 1985
- Decision date
- December 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
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| K884993 | Visual Blood Glucose Test SystemCGA · Traditional | 12/29/1988SE |
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| K880787 | Easy-Test Lactic Acid (la)KHP · Traditional | 03/15/1988SE |
| K862403 | Emds Antiepileptic Drug Calibrators Item #67630/95DKB · Traditional | 07/11/1986SE |
| K853699 | Easy Analyzer & Easy-Test ReagentJJE · Traditional | 09/25/1985SE |
| K853533 | Absorbance Test SolutionJIT · Traditional | 09/16/1985SE |
Questions and answers
When was Absorbance (Abs) Test Pak cleared by the FDA?
Absorbance (Abs) Test Pak (K854784) received a 510(k) decision of Substantially Equivalent on December 19, 1985, 20 days after the submission was received.
What is the product code of K854784?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.