Centrifichem Filter Calibration Set
FDA 510(k) K800304 · Union Carbide Corp.
510(k) numberK800304
Submission
- Device name
- Centrifichem Filter Calibration Set
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- February 12, 1980
- Decision date
- March 12, 1980
- 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
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| K892213 | Acs Colloid Osmotic Pressure CalibratorJIW · Traditional | Analytical Control Systems, Inc. | 06/21/1989SE |
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| 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 |
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| K812536 | Linde Mark IIBYJ · Traditional | 09/23/1981SE |
| K810732 | Linde Mark II Oxygen Reserv. Type OR-4BYJ · Traditional | 03/27/1981SE |
| K810596 | Centrifi Chem System 400 AnalyzerJJE · Traditional | 03/17/1981SE |
| K810129 | Centrifichem System 500JJE · Traditional | 02/02/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
| K802741 | Centrifichem Comb. Serum-Based Calib.JIX · Traditional | 12/10/1980SE |
| K802520 | Centrifichem Pipettor Accuracy Calib.JQW · Traditional | 11/12/1980SE |
Questions and answers
When was Centrifichem Filter Calibration Set cleared by the FDA?
Centrifichem Filter Calibration Set (K800304) received a 510(k) decision of Substantially Equivalent on March 12, 1980, 29 days after the submission was received.
What is the product code of K800304?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.