Suzhou Precigenome, Ltd. Co; FDA Record
Suzhou Precigenome, Ltd. Co; has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Suzhou Precigenome, Ltd. Co;" is on file.
- Latest 510(k)
- Jul 2, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K252243 | Fastplex BCR-ABL (p210) %IS digital PCR Kit | Jul 2, 2026 |
Suzhou Precigenome, Ltd. Co; and the FDA: common questions
Has Suzhou Precigenome, Ltd. Co; received an FDA warning letter?
No FDA warning letter addressed to the name "Suzhou Precigenome, Ltd. Co;" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Suzhou Precigenome, Ltd. Co; received an FDA Form 483?
FDA has not published a Form 483 for "Suzhou Precigenome, Ltd. Co;" in its reading room. FDA publishes some Form 483s, not all of them.
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