Precipath(R) Im Normal & Abnormal Immuno. Control
FDA 510(k) K902220 · Boehringer Mannheim Corp.
510(k) numberK902220
Submission
- Device name
- Precipath(R) Im Normal & Abnormal Immuno. Control
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- May 17, 1990
- Decision date
- September 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DGR – Whole Human Serum, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5700
- Specialty
- Immunology
Other 510(k)s with product code DGR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961544 | Qualitrol Igame Controls, Levels 1 and 2DGR · Traditional | Consolidated Technologies, Inc. | 09/24/1996SE |
| K865014 | Liquichek Immunology Control (Human) Levels I & IIDGR · Traditional | Bio-Rad | 01/09/1987SE |
| K790298 | Radioassay, Control Serum I, II, IIIDGR · Traditional | Kallestad Laboratories, Inc. | 04/04/1979SE |
| K781355 | Ics Normal Control SerumDGR · Traditional | Beckman Instruments, Inc. | 08/31/1978SE |
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| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Precipath(R) Im Normal & Abnormal Immuno. Control cleared by the FDA?
Precipath(R) Im Normal & Abnormal Immuno. Control (K902220) received a 510(k) decision of Substantially Equivalent on September 5, 1990, 111 days after the submission was received.
What is the product code of K902220?
The FDA product code is DGR – Whole Human Serum, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5700.