Behring Polaroid Opus Theophylline
FDA 510(k) K885044 · Pb Diagnostic Systems, Inc.
510(k) numberK885044
Submission
- Device name
- Behring Polaroid Opus Theophylline
- Applicant
- Pb Diagnostic Systems, Inc.
Westwood, MA, US - Received
- December 5, 1988
- Decision date
- December 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLS – Enzyme Immunoassay, Theophylline
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3880
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042520 | Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IIIKLS · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/30/2004SE |
| K042407 | Emit Caffeine AssayKLS · Traditional | Dade Behring, Inc. | 10/28/2004SE |
| K020740 | Roche Online TheophyllineKLS · Traditional | Roche Diagnostics Corp. | 04/16/2002SE |
| K011771 | Randox TheophyllineKLS · Traditional | Randox Laboratories, Ltd. | 01/17/2002SE |
| K013272 | Acs: 180 and Advia Centaur Theophylline 2 AssayKLS · Special | Bayer Corp. | 10/25/2001SE |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229KLS · Special | Syva Co., Dade Behring, Inc. | 05/10/2001SE |
| K993029 | Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89KLS · Traditional | Syva Co. | 01/27/2000SE |
| K973583 | Ace Theophylline Reagent, Theo CalibratorsKLS · Traditional | Schiapparelli Biosystems, Inc. | 11/12/1997SE |
| K972495 | Accumeter Theophylline TestKLS · Traditional | Chemtrak, Inc. | 10/10/1997SE |
| K961462 | Cedia Theophylline AssayKLS · Traditional | Boehringer Mannheim Corp. | 06/27/1996SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K940507 | Opus FT4 Test SystemCEC · Traditional | 07/28/1994SE |
| K934762 | Opus Procainamide Test SystemLAR · Traditional | 07/20/1994SE |
| K933389 | Opus Cmv-GLFZ · Traditional | 06/28/1994SE |
| K934137 | Opus(R) Serology Controls, ModificationMJX · Traditional | 03/07/1994SE |
| K935229 | Opus DigitoxinDPG · Traditional | 12/22/1993SE |
| K934705 | Opus NapaLAN · Traditional | 11/22/1993SE |
| K933675 | Opus Total CKCGS · Traditional | 09/08/1993SE |
| K933066 | Opus EstradiolCHP · Traditional | 09/08/1993SE |
| K932279 | Opus(R) Total B-Hcg Test SystemJHI · Traditional | 07/08/1993SE |
| K926131 | Opus Magnum AnalyzerKHO · Traditional | 06/07/1993SE |
Questions and answers
When was Behring Polaroid Opus Theophylline cleared by the FDA?
Behring Polaroid Opus Theophylline (K885044) received a 510(k) decision of Substantially Equivalent on December 29, 1988, 24 days after the submission was received.
What is the product code of K885044?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.