Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed Liquid Chemistry Control Levels
FDA 510(k) K973469 · Consolidated Technologies, Inc.
510(k) numberK973469
Submission
- Device name
- Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed Liquid Chemistry Control Levels
- Applicant
- Consolidated Technologies, Inc.
Austin, TX, US - Received
- September 4, 1997
- Decision date
- September 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
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More from Aalto Scientific, Ltd.
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| K992576 | Urine Chemistry Control, Level 1JJW · Traditional | 09/03/1999SE |
| K992151 | Reference Material for DELTA-9-THC-COOH in Human UrineLAS · Traditional | 07/14/1999SE |
| K981339 | Quickcheck Lyophilized Chemistry Control Conformance Chemistry Control C3JJY · Traditional | 04/21/1998SE |
| K974699 | Reference Material for Amphetamine/Methamphetamine in Human UrineDKB · Traditional | 01/22/1998SE |
| K972146 | Qualitrol Unassayed H. Pylori Control Set Positive and Negative ControlsLYR · Traditional | 07/08/1997SE |
| K972080 | Qualitrol DHP Immunoassay Control Levels 1,2 and 3, Conformancee Mcc-Ligand Control…JJY · Traditional | 06/18/1997SE |
| K961815 | Qualitrol Ana Control Serum SetLKJ · Traditional | 09/27/1996SE |
| K961550 | Qualitrol Mono Control Serum SetKTN · Traditional | 09/24/1996SE |
Questions and answers
When was Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed Liquid Chemistry Control Levels cleared by the FDA?
Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed Liquid Chemistry Control Levels (K973469) received a 510(k) decision of Substantially Equivalent on September 25, 1997, 21 days after the submission was received.
What is the product code of K973469?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.