Kitazato Biopharma Co., Ltd. FDA Record
- No warning letters matched by name
Kitazato Biopharma Co., Ltd. has 0 FDA recalls, 0 inspections, 6 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kitazato Biopharma Co., Ltd." is on file.
- Latest 510(k)
- Oct 7, 2016
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 6 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 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 |
|---|---|---|
| K160864 | Cryotop Vitrification Kit and Cryotop Thawing Kit | Oct 7, 2016 |
| K160863 | PBS(-), Phosphate Buffered Saline | Jul 28, 2016 |
| K160142 | MINERAL OIL | Apr 21, 2016 |
| K153027 | Cryotop US | Mar 14, 2016 |
| K140072 | CRYOTOP(R) SC | Apr 3, 2014 |
| K112695 | CRYOTOP | Dec 12, 2012 |
Kitazato Biopharma Co., Ltd. and the FDA: common questions
Has Kitazato Biopharma Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Kitazato Biopharma Co., Ltd." 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 Kitazato Biopharma Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Kitazato Biopharma Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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