Freshcells
FDA 510(k) K972414 · Diagnostic Hybrids, Inc.
510(k) numberK972414
Submission
- Device name
- Freshcells
- Applicant
- Diagnostic Hybrids, Inc.
Athens, OH, US - Received
- June 27, 1997
- Decision date
- August 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KIR – Cells, Animal And Human, Cultured
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2280
- Specialty
- Hematology
Other 510(k)s with product code KIR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973214 | Fresh Cells HFFKIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973213 | Fresh Cells LLC-MK2KIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973212 | Fresh Cells WI-38KIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973211 | Fresh Cells MV1LUKIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973210 | Fresh Cells Nci H292KIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973209 | Fresh Cells VeroKIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K971508 | RHMK II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell CultureKIR · Traditional | Bio-Whittaker, Inc., A Cambrex Co. | 09/17/1997SE |
| K965047 | Mink Lung Cell CultureKIR · Traditional | Neogenex | 02/04/1997SE |
| K962782 | Freshfrozen Cells, HEP-2KIR · Traditional | Diagnostic Hybrids, Inc. | 08/29/1996SE |
| K962780 | Freshcells, HEP-2KIR · Traditional | Diagnostic Hybrids, Inc. | 08/29/1996SE |
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|---|---|---|
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| K092882 | D3 Fastpoint L-Dfa Influenza A/Influenza B Virus Identification KitGNW · Traditional | 10/21/2009SE |
| K091171 | D3 Ultra Duet Dfa Respiratory Virus Identification KitOMG · Traditional | 09/11/2009SE |
| K092300 | Modification to D3 Ultra Dfa Respiratory Virus Screening & Id KitGNW · Special | 08/28/2009SE |
| K091753 | Elvis HSV Id and D3 Typing Test SystemGQL · Traditional | 08/28/2009SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | 05/21/2009SE |
| K090073 | D3 Dfa Metapneumovirus Identification KitOMG · Traditional | 03/06/2009SE |
| K081928 | D3 Duet Dfa Rsv/Respiratory Virus Screening KitLKT · Traditional | 12/23/2008SE |
Questions and answers
When was Freshcells cleared by the FDA?
Freshcells (K972414) received a 510(k) decision of Substantially Equivalent on August 29, 1997, 63 days after the submission was received.
What is the product code of K972414?
The FDA product code is KIR – Cells, Animal And Human, Cultured, a Class I (low risk) device regulated under 21 CFR 864.2280.