Il Test Dat Cal/Control Set D/E
FDA 510(k) K920419 · Instrumentation Laboratory CO
510(k) numberK920419
Submission
- Device name
- Il Test Dat Cal/Control Set D/E
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- January 31, 1992
- Decision date
- March 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DLG – Coating, Liquid, Glc
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2250
- Specialty
- Clinical Chemistry
Other 510(k)s with product code DLG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050988 | Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and ControlsDLG · Traditional | Lin-Zhi International, Inc. | 04/06/2006SE |
| K894524 | FPR Gentamicin Calibrator KitDLG · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K894518 | FPR Amikacin Calibrator KitDLG · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K894528 | FPR Phenytoin Calibrator KitDLG · Traditional | Colony Laboratories, Inc. | 09/25/1989SE |
| K882766 | Emds Acetaminophen Calibrator No. 67636/95DLG · Traditional | Em Diagnostic Systems, Inc. | 08/23/1988SE |
| K833385 | N-Acetylprocainamide CalibratorDLG · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 12/16/1983SE |
More from E.I. Dupont DE Nemours & Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | 12/13/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
Questions and answers
When was Il Test Dat Cal/Control Set D/E cleared by the FDA?
Il Test Dat Cal/Control Set D/E (K920419) received a 510(k) decision of Substantially Equivalent on March 11, 1992, 40 days after the submission was received.
What is the product code of K920419?
The FDA product code is DLG – Coating, Liquid, Glc, a Class I (low risk) device regulated under 21 CFR 862.2250.