The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Cd-chex + Rbc.
Device ID | K960894 |
510k Number | K960894 |
Device Name: | CD-CHEX + RBC |
Classification | Control, White-cell |
Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
Contact | Theodore W Heise |
Correspondent | Theodore W Heise STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
Product Code | GGL |
CFR Regulation Number | 864.8625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-05 |
Decision Date | 1996-05-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00844509000174 | K960894 | 000 |
20844509000093 | K960894 | 000 |
20844509000130 | K960894 | 000 |
20844509000147 | K960894 | 000 |
30844509000083 | K960894 | 000 |
30844509000090 | K960894 | 000 |
30844509000137 | K960894 | 000 |
30844509000144 | K960894 | 000 |
40844509000080 | K960894 | 000 |
40844509000134 | K960894 | 000 |
40844509000141 | K960894 | 000 |
00844509000105 | K960894 | 000 |
00844509000112 | K960894 | 000 |
00844509000129 | K960894 | 000 |
00844509000150 | K960894 | 000 |
00844509000167 | K960894 | 000 |
20844509000086 | K960894 | 000 |