Labeling Change Coat-A-Count Methaqualone
FDA 510(k) K873759 · Diagnostic Products Corp.
510(k) numberK873759
Submission
- Device name
- Labeling Change Coat-A-Count Methaqualone
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- September 4, 1987
- Decision date
- October 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KXS – Radioimmunoassay, Methaqualone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3630
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KXS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011164 | Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229KXS · Special | Syva Co., Dade Behring, Inc. | 05/10/2001SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | Syva Co. | 01/27/2000SE |
| K955676 | Synchron Systems Methaqualone ReagentKXS · Traditional | Beckman Instruments, Inc. | 03/04/1996SE |
| K945187 | Roche Abuscreen Online for MethaqualoneKXS · Traditional | Roche Diagnostic Systems, Inc. | 04/05/1995SE |
| K940123 | Methaqualone Enzyme ImmunoassayKXS · Traditional | Diagnostic Reagents, Inc. | 05/03/1994SE |
| K921013 | Syva Emit II Methaqualone AssayKXS · Traditional | Syva Co. | 05/13/1992SE |
| K874272 | Revised Labeling for Methaqualone Test KitKXS · Traditional | Roche Diagnostic Systems, Inc. | 11/13/1987SE |
| K874199 | Revised Labeling for Syva Methaqualone AssaysKXS · Traditional | Syva Co. | 10/28/1987SE |
| K870935 | Coat-A-Count Methaqualone TKMQ1KXS · Traditional | Diagnostic Products Corp. | 03/19/1987SE |
| K843605 | Emit 700 Methaqualone AssayKXS · Traditional | Syva Co. | 10/05/1984SE |
More from Syva Co.
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|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| 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 Labeling Change Coat-A-Count Methaqualone cleared by the FDA?
Labeling Change Coat-A-Count Methaqualone (K873759) received a 510(k) decision of Substantially Equivalent on October 15, 1987, 41 days after the submission was received.
What is the product code of K873759?
The FDA product code is KXS – Radioimmunoassay, Methaqualone, a Class II (moderate risk) device regulated under 21 CFR 862.3630.