Cryocheck Weak Lupus Positive Control
FDA 510(k) K032804 · Precision Biologic
510(k) numberK032804
Submission
- Device name
- Cryocheck Weak Lupus Positive Control
- Applicant
- Precision Biologic
Dartmouth, N.S., CA - Received
- September 9, 2003
- Decision date
- November 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGC – Control, Plasma, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K060284 | Cryocheck Clot ApcrGGW · Traditional | 05/10/2006SE |
| K043571 | Cryocheck Clot SGGP · Traditional | 03/18/2005SE |
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Questions and answers
When was Cryocheck Weak Lupus Positive Control cleared by the FDA?
Cryocheck Weak Lupus Positive Control (K032804) received a 510(k) decision of Substantially Equivalent on November 3, 2003, 55 days after the submission was received.
What is the product code of K032804?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.