Quick-Chem Calibration Set
FDA 510(k) K852260 · Seragen Diagnostics, Inc.
510(k) numberK852260
Submission
- Device name
- Quick-Chem Calibration Set
- Applicant
- Seragen Diagnostics, Inc.
Indianapolis, IN, US - Received
- May 24, 1985
- Decision date
- July 22, 1985
- 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
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|---|---|---|---|
| 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 |
| K902575 | Sopheia 1000 (S1CAL) & Sopheia 2000 (S2CAL)JIW · Traditional | Diagnostic Products Corp. | 10/04/1990SE |
| 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 |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K872148 | Vivid Chlamydia(Tm)LJC · Traditional | 08/19/1987SE |
| K851663 | Quick-Count Hematology ControlsJPK · Traditional | 07/23/1985SE |
| K851520 | Ck/Ld Isoenzymes Controls(Human)JJT · Traditional | 06/25/1985SE |
| K851521 | LD-1(IMMUNO) Separation SetCEX · Traditional | 05/10/1985SE |
| K850209 | Quick-LyteJGS · Traditional | 02/27/1985SE |
| K844743 | Seratest Ena(Rnp/Sm) DeterminationLLL · Traditional | 02/04/1985SE |
| K842563 | Seratest DNA DeterminationLKJ · Traditional | 10/25/1984SE |
| K841504 | Quick-Count Plus 2GKL · Traditional | 06/11/1984SE |
| K840793 | Ck/Mb Immuno-Isoenzyme Control SerumJJT · Traditional | 04/13/1984SE |
| K840863 | Seratest RF Latex DeterminationDHR · Traditional | 04/04/1984SE |
Questions and answers
When was Quick-Chem Calibration Set cleared by the FDA?
Quick-Chem Calibration Set (K852260) received a 510(k) decision of Substantially Equivalent on July 22, 1985, 59 days after the submission was received.
What is the product code of K852260?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.