Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13K
FDA 510(k) K990957 · Astoria-Pacific, Inc.
510(k) numberK990957
Submission
- Device name
- Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13K
- Applicant
- Astoria-Pacific, Inc.
Clackamas, OR, US - Received
- March 22, 1999
- Decision date
- May 11, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JBL – Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7360
- Specialty
- Hematology
Other 510(k)s with product code JBL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K790211 | Dehydrogenose, Glucose PhosphateJBL · Traditional | Sigma Chemical Co. | 03/15/1979SE |
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Questions and answers
When was Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13K cleared by the FDA?
Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13K (K990957) received a 510(k) decision of Substantially Equivalent on May 11, 1999, 50 days after the submission was received.
What is the product code of K990957?
The FDA product code is JBL – Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative, a Class II (moderate risk) device regulated under 21 CFR 864.7360.