CELL SCRAPER
FDA 510(k) clearance K823138 · decided 1982-11-29
Clearance details
- K-number
- K823138
- Device name
- CELL SCRAPER
- Applicant
- Corning Costar Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-10-25
- Decision date
- 1982-11-29
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- KJA
- Device class
- 1
- Regulation number
- 864.2240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) (K972404) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-07-22 |
| KAPTON PEEL POUCH (K933228) | American Fluoroseal Corp. | 1994-03-30 |
| CELL SCRAPER (K885121) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-12-28 |
| TISSUE CULTURE FLASKS (K873890) | Nunc, Inc. | 1987-11-25 |
| TISSUE CULTURE TUBES (K873889) | Nunc, Inc. | 1987-11-25 |
| DU PONT STERICELL CELL CULTURE SYSTEM (K871324) | E.I. Dupont DE Nemours & Co., Inc. | 1987-04-14 |
| TISSUE CULTURE BAG (K870865) | American Fluoroseal Corp. | 1987-03-30 |
| TISSUE CULTURE FLASK (K864021) | Fenwal Laboratories | 1986-10-29 |
| TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD (K862152) | Travenol Laboratories, S.A. | 1986-06-16 |
| TISSUE CULTURE FLASK PL 732 PLASTIC (K861253) | Travenol Laboratories, S.A. | 1986-04-11 |
| FETAL BOVINE SERUM IN TRANSFER CONTAINER (K853441) | Newport Biosystems, Inc. | 1985-08-26 |
| NEWPORT MEDIA TRANSFER CONTAINER (K852532) | Newport Bio Systems | 1985-08-22 |
Recalls involving this device
No recalls on record reference this clearance.