RHMK II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell Culture
FDA 510(k) K971508 · Bio-Whittaker, Inc., A Cambrex Co.
510(k) numberK971508
Submission
- Device name
- RHMK II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell Culture
- Applicant
- Bio-Whittaker, Inc., A Cambrex Co.
Walkersville, MD, US - Received
- April 25, 1997
- Decision date
- September 17, 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
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|---|---|---|---|
| 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 |
| K972414 | FreshcellsKIR · Traditional | Diagnostic Hybrids, Inc. | 08/29/1997SE |
| 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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Questions and answers
When was RHMK II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell Culture cleared by the FDA?
RHMK II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell Culture (K971508) received a 510(k) decision of Substantially Equivalent on September 17, 1997, 145 days after the submission was received.
What is the product code of K971508?
The FDA product code is KIR – Cells, Animal And Human, Cultured, a Class I (low risk) device regulated under 21 CFR 864.2280.