The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R & D Batteries, Inc. Part Numbers 5296, 5479, 5351, & 5470.
| Device ID | K934747 |
| 510k Number | K934747 |
| Device Name: | R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | R & D BATTERIES, INC. P.O. BOX 5007 Burnsville, MN 55337 |
| Contact | Randall C Noddings |
| Correspondent | Randall C Noddings R & D BATTERIES, INC. P.O. BOX 5007 Burnsville, MN 55337 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-04 |
| Decision Date | 1993-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810149096969 | K934747 | 000 |
| 00810149095542 | K934747 | 000 |
| 00810149093258 | K934747 | 000 |
| 00810149092749 | K934747 | 000 |
| 00810149092626 | K934747 | 000 |
| 00810149092619 | K934747 | 000 |
| 00810149091681 | K934747 | 000 |
| 00810149090622 | K934747 | 000 |