Calbiochem-Behring Laser Immunoglobulin
FDA 510(k) K790330 · Calbiochem-Behring Corp.
510(k) numberK790330
Submission
- Device name
- Calbiochem-Behring Laser Immunoglobulin
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- February 16, 1979
- Decision date
- March 15, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| 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 |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
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| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
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Questions and answers
When was Calbiochem-Behring Laser Immunoglobulin cleared by the FDA?
Calbiochem-Behring Laser Immunoglobulin (K790330) received a 510(k) decision of Substantially Equivalent on March 15, 1979, 27 days after the submission was received.
What is the product code of K790330?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.