Quantimetrix Bilirubin Calibrators
FDA 510(k) K895778 · Quantimetrix Medical Industries
510(k) numberK895778
Submission
- Device name
- Quantimetrix Bilirubin Calibrators
- Applicant
- Quantimetrix Medical Industries
Hawthorne, CA, US - Received
- September 27, 1989
- Decision date
- November 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K061251 | Dimension Vista Total Iron Binding Capacity CalibratorJIS · Traditional | Dade Behring, Inc. | 05/31/2006SE |
| K060266 | Dimension Iron CalibratorJIS · Traditional | Dade Behring, Inc. | 03/09/2006SE |
| K053104 | Dimension Cardiophase High Sensitivity C-Reactive Protein CalibratorJIS · Traditional | Dade Behring, Inc. | 12/23/2005SE |
| K032697 | Dimension Total Triiodothyronine Calibrator (RC414)JIS · Traditional | Dade Behring, Inc. | 11/07/2003SE |
| K032608 | Gonotec Calibration Solution 300 Mosmol/Kg for OsmometerJIS · Abbreviated | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 10/21/2003SE |
| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsJIS · Special | Ortho-Clinical Diagnostics, Inc. | 08/13/2003SE |
| K030964 | Calibration Plasma LMW HeparinJIS · Traditional | Instrumentation Laboratory CO | 06/06/2003SE |
| K030546 | CRP (II) CalibratorsJIS · Traditional | Denka Seiken Co., Ltd. | 06/02/2003SE |
| K030320 | Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control SetJIS · Traditional | Wako Chemicals USA, Inc. | 04/11/2003SE |
More from Wako Chemicals USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883395 | Alkphor(Tm) System, Human Serum Alka Phos IsoenzyJJT · Traditional | 09/19/1988SE |
| K883247 | Lipophor(Tm) Syst, Human Serum Lipoprotein ControlJJY · Traditional | 09/13/1988SE |
| K874302 | Quantimetrix Total Creatine Kinase ControlJJT · Traditional | 02/02/1988SE |
| K874890 | Quantimetrix Urine Dipstick ControlJJW · Traditional | 01/21/1988SE |
| K873011 | Quantimetrix Serum Alcohol Control Level 1 and 2LAS · Traditional | 10/29/1987SE |
| K873467 | Quantimetrix Urine Drugs of Abuse ControlDIF · Traditional | 09/29/1987SE |
| K861448 | Quantimetrix Serum Lipid Control I & II LiquidJJY · Traditional | 04/28/1986SE |
Questions and answers
When was Quantimetrix Bilirubin Calibrators cleared by the FDA?
Quantimetrix Bilirubin Calibrators (K895778) received a 510(k) decision of Substantially Equivalent on November 14, 1989, 48 days after the submission was received.
What is the product code of K895778?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.