Chrom-Trol Cat. No. 5300 W/ New Analyte
FDA 510(k) K902083 · Helena Laboratories
510(k) numberK902083
Submission
- Device name
- Chrom-Trol Cat. No. 5300 W/ New Analyte
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- May 7, 1990
- Decision date
- June 15, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GJT – Plasma, Coagulation Factor Deficient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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|---|---|---|---|
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| K102908 | Nofact IxGJT · Traditional | R2 Diagnostics, Inc. | 12/19/2011SE |
| K102851 | Nofact ViiiGJT · Traditional | R2 Diagnostics, Inc. | 12/19/2011SE |
| K110237 | Hemosil Factor Viii Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 07/08/2011SE |
| K050661 | Hemosil Factor II Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 05/02/2005SE |
| K043459 | Hemosil Factor Xii Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 02/09/2005SE |
| K040362 | Diapharma Factor X KitGJT · Traditional | Diapharma Group, Inc. | 07/12/2004SE |
| K034007 | Hemosil Factor Viii Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 02/13/2004SE |
| K031829 | Hemosil Factor Ix Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 07/31/2003SE |
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Questions and answers
When was Chrom-Trol Cat. No. 5300 W/ New Analyte cleared by the FDA?
Chrom-Trol Cat. No. 5300 W/ New Analyte (K902083) received a 510(k) decision of Substantially Equivalent on June 15, 1990, 39 days after the submission was received.
What is the product code of K902083?
The FDA product code is GJT – Plasma, Coagulation Factor Deficient, a Class II (moderate risk) device regulated under 21 CFR 864.7290.