Sopheia 1000 (S1CAL) & Sopheia 2000 (S2CAL)
FDA 510(k) K902575 · Diagnostic Products Corp.
510(k) numberK902575
Submission
- Device name
- Sopheia 1000 (S1CAL) & Sopheia 2000 (S2CAL)
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- June 11, 1990
- Decision date
- October 4, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIW – Calibrator, Surrogate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973055 | Wako CH50 Linearity SetJIW · Traditional | Wako Chemicals USA, Inc. | 09/25/1997SE |
| K970396 | Human Chorionic Gonadotropin CalibratorJIW · Traditional | Dade Chemistry Systems, Inc. | 02/20/1997SE |
| K910255 | Flow Cytometry Fitc/Pe Compensation KitJIW · Traditional | Sigma Diagnostics, Inc. | 04/03/1991SE |
| K902294 | Accuscan Microbead StandardsJIW · Traditional | Sigma Chemical Co. | 07/03/1990SE |
| K892213 | Acs Colloid Osmotic Pressure CalibratorJIW · Traditional | Analytical Control Systems, Inc. | 06/21/1989SE |
| K883389 | Raichem(Tm) Bilirubin Conjugate StandardJIW · Traditional | Reagents Applications, Inc. | 12/14/1988SE |
| K882220 | Calibration KitJIW · Traditional | King Diagnostics, Inc. | 08/02/1988SE |
| K880654 | Amresco Liquizyme Glucose/Bun Standard 0124, 0200JIW · Traditional | American Research Products Co. | 06/07/1988SE |
| K880610 | Unimeter Calibration KitJIW · Traditional | Boehringer Mannheim Corp. | 03/24/1988SE |
| K854028 | Audit Automated Blood Chemistry AnalyzerJIW · Traditional | Verified Medical Research, Inc. | 12/02/1985SE |
More from Verified Medical Research, Inc.
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|---|---|---|
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| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Sopheia 1000 (S1CAL) & Sopheia 2000 (S2CAL) cleared by the FDA?
Sopheia 1000 (S1CAL) & Sopheia 2000 (S2CAL) (K902575) received a 510(k) decision of Substantially Equivalent on October 4, 1990, 115 days after the submission was received.
What is the product code of K902575?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.