510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KIPClass I

Formulations, Balanced Salt Solutions

21 CFR 864.2875 / Hematology
FDA source (opens on fda.gov)

KIP is the FDA product code for Formulations, Balanced Salt Solutions, a class I device type, regulated under 21 CFR 864.2875. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KIP
Device name
Formulations, Balanced Salt Solutions
Regulation
21 CFR 864.2875
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
17
Ingested recalls
0

Clearances, product code KIP

By decision year
17 clearances under product code KIP with a decision year between 1978 and 1987, 1987 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KIP by decision year
YearClearances
19781
19813
19823
19843
19852
19861
19874

Applicants with the most clearances

Product code KIP
Applicants holding the most 510(k) clearances under product code KIP
ApplicantClearances
Dutchland Laboratories, Inc.6
Sigma Chemical Co.4
E K Ind., Inc.3
Hazleton Research Products, Inc.2
Flow Laboratories, Inc.1
Tissue Culture Innovations1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order